SAJBL Vol 10, No 2 (2017) by HMPG

ISSN 1999-7639

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW DECEMBER 2017 Vol. 10 No. 2

SAJBL is published by the Health and Medical Publishing Group.

THE SOUTH AFRICAN JOURNAL OF

BIOETHICS & LAW DECEMBER 2017 Vol. 10 No. 2

CONTENTS 40

EDITORIAL The Life Esidimeni tragedy: Constitutional oath betrayed A Dhai

ARTICLES: LIFE ESIDIMENI 42 Life Esidimeni psychiatric patients in Gauteng Province, South Africa: Clinicians’ voices and activism – an ongoing, but submerged narrative B Janse van Rensburg 46 Following on from the Life Esidimeni incident – access to care for people living with severe mental disability, according to national policy B Janse van Rensburg 50 The Life Esidimeni tragedy: A human-rights perspective B A Ferlito, A Dhai CORRESPONDENCE 54 Were ethical and legal issues violated, or was the book Mandela’s Last Days censored? M A Sathar ARTICLES 56 Deferential vulnerability and patient decision-making C Ellis 58 Informed consent and deafness in South Africa: Guidelines for clinicians and researchers C Penn, V de Andrade 62

Password compliance for PACS work stations: Implications for emergency-driven medical environments T B Mahlaola, B van Dyk

67 Do doctors attending sexual-offence victims have to notify sexualoffence suspects that their patients who were forced to have unprotected sexual intercourse are HIV-positive? What should doctors do? D J McQuoid-Mason 69 Transparency in medicines regulatory affairs – reclaiming missed opportunities Y A Vawda, A Gray 75

How do healthcare professionals manage ethical challenges regarding information in healthcare professional/patient clinical interactions? A review of concept- or argument-based articles and case analyses C Ewuoso, S Hall, K Dierickx

EDITOR Ames Dhai. Wits CO-EDITOR David McQuoid-Mason. UKZN EDITORIAL BOARD David J McQuoid-Mason. UKZN Freddy Mnyongani. UNISA Liz Gwyther. UCT Leslie London. UCT Peter Cleaton-Jones. Wits J P van Niekerk. HMPG Joseph Mfutso-Bengo. University of Malawi Godfrey B Tangwa. University of Yaounde Alexander Morgan Capron. University of S California Daniel Wikler. Harvard TH Chan School HMPG CEO AND PUBLISHER Hannah Kikaya Email:hannahk@hmpg.co.za EXECUTIVE EDITOR Bridget Farham MANAGING EDITORS Claudia Naidu Naadia van der Bergh TECHNICAL EDITOR Kirsten Morreira PRODUCTION AND ADMINISTRATION MANAGER Emma Jane Couzens DESIGN AND LAYOUT Clinton Griffin Travis Arendse CUSTOMER SERVICE AND ONLINE SUPPORT Gertrude Fani FINANCE AND ADMINISTRATION Tshepiso Mokoena HMPG BOARD OF DIRECTORS Prof. M Lukhele (Chair) Dr M R Abbas Mrs H Kikaya Dr M Mbokota Dr G Wolvaardt ISSN 1999-7639

A study of the role and functions of inspectors of anatomy in South Africa P Pillay, D J McQuoid-Mason, K Satyapal

The 2016 CIOMS guidelines and public-health research ethics J R Williams

End-of-life practices: The opinions of undergraduate medical students at a South African university C Marais, J Smouse, G Poortier, A Fair, G Joubert, W J Steinberg

102 CPD

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EDITORIAL

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

The Life Esidimeni tragedy: Constitutional oath betrayed A Dhai, MB ChB, FCOG, LLM, PGDip Int Res Ethic, PhD Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg

Ames Dhai Editor amaboo.dhai@wits.ac.za The editorial in the previous issue of the South African Journal of Bioethics and Law discussed the Gauteng Mental Health Marathon Project (GMMP), or the Life Esidimeni (LE) tragedy, as it is better known, and examined the lip-service paid to South Africa (SA)’s Constitution by certain state actors.[1] At the time of writing this editorial, an arbitration process, chaired by Justice Dikgang Moseneke, is underway with the families of the deceased and some of the survivors of the disaster. The number of dead has thus far increased to 143, and 59 are as yet unaccounted for. During this process, SA has been witness to further startling revelations beyond those noted in the health ombud’s report.[2] In addition, stubborn evasion has been the pattern by state actors during this process. This editorial continues the discussion on SA’s Constitutional promise, but focuses it on the office of Q D Mahlangu, previously the member of the executive council (MEC) for Gauteng Province in charge of health. As a member of a provincial executive council, Mahlangu was required to take an oath (or solemn affirmation) in line with schedule 2, section 5 of the Constitution of the Republic of SA[3] when sworn in. The Constitutional requirements are as follows: ‘Oath or solemn affirmation of Premiers, Acting Premiers and members of provincial Executive Councils: The Premier or Acting Premier of a province, and each member of the Executive Council of a province, before the President of the Constitutional Court or a judge designated by the President of the Constitutional Court, must swear/affirm as follows: I, A.B. swear/solemnly affirm that I will be faithful to the Republic of South Africa and will obey, respect and uphold the Constitution and all other law of the Republic; and I undertake to hold my office as Premier/Acting Premier/member of the Executive Council of the province of C.D. with honour and dignity; to be a true and faithful counsellor; not to divulge directly or indirectly any secret matter entrusted to me; and to perform the functions of my office conscientiously and to the best of my ability.’

According to the ombud’s report,[2] the MEC was not aware of the total number of patients who had died in a project that she had authorised during the ‘conscientious’ performance of a function of her office. While she indicated in an interview with the ombud during the enquiry that he headed into the LE tragedy that the decision was a collective one, and not hers individually, and that there were no dissenting views in their meetings, she is alleged by many to have said that ‘her decision is final and non-negotiable and the project had to be done’, and that she left no room for ‘engagement’. Staff members felt powerless and had to deliver to her the outcome of a project they did not believe in – a cost reduction from ZAR320/day in LE, to ZAR112/day at the non-governmental organisations to which the patients were sent. He goes on to state that there was a general culture of fear and disempowerment among staff that hampered them from challenging or engaging with authority. There was an overwhelming revelation of frustration and disempowerment, which came from across all sectors of the department below the director’s level, during oral evidence gathered in the enquiry. The MEC was bound by the oath she took when sworn in as a public servant at the level of the provincial executive council to ensure the realisation of the Constitutional promises to the patients and families in the LE tragedy. Moreover, she was also bound to function conscientiously and with honour and dignity, and respect for the worth and value felt by and bestowed on persons. By not abiding by this oath, not only did she wrong the patients and families, but she also disgraced her office and brought it into disrepute. She abused the power of her office and used it to mete out a ‘reign of terror’ similar to that of a repressive state, resulting in moral distress for staff members who powerlessly tried to deliver to her the outcome of a project they did not believe in. Furthermore, instead of humanitarian considerations, the project focused on narrow economic ones. Of note is that, during the interview, the MEC stated that ‘when a policy decision is taken, you don’t know how it will unfold and what is going to happen … the risks associated with it.’ Implementing a policy decision without having any idea of its feasibility and ‘how it would unfold’ contradicts the Ekurhuleni Declaration on Mental Health of April 2012,[4] where a commitment was made that all users of mental-health services would participate in the planning, implementation, monitoring and evaluation of mental-health services and programmes. With proper planning that included all stakeholders, and assessing whether the policy was operationally and administratively feasible, possibly by a pilot programme, the tragedy could have been averted. The declaration also commits to physical infrastructure that is conducive to the needs and human rights of people with mental disorders and disabilities. As MEC, the ultimate responsibility resided with her – she did not ensure that their accommodation needs were provided for and that their human rights were respected. Providing equitable,

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EDITORIAL cost-effective and evidence-based interventions is an additional commitment of the declaration. Deinstitutionalising patients into the community was an intervention in mental healthcare – however, when implemented, it was not evidence based. Because the deinstitutionalising intervention was not evidence based, and because of her statement on not knowing how a policy decision could unfold, the GMMP can be likened to an experiment. One of the definitions of experiment is ‘a course of action tentatively adopted without being sure of its outcome’.[5] Therefore, the GMMP could be perceived as one massive experiment that included highly vulnerable subjects who, because of this vulnerability being exploited, suffered serious harms and wrongs. The entire project, with patients being herded and taken to ‘concentration camps’, as described by families, and subjected to cruel, degrading and inhumane conditions, is a distressing reminder of Hitler’s Nazi war atrocities, where the vulnerable were considered to be subhuman, of lesser intelligence, of no moral status and lacking human dignity – and hence exploitable. What is highlighted by this tragedy is the political appointment of a member of the provincial executive to run the provincial Department of Health who either did not understand or chose to ignore the Constitutional oath she took when sworn in. She ran her department similarly to an authoritarian leader in a repressive state, and betrayed that oath. Furthermore, she was not trained as a healthcare professional, and therefore had limited to no understanding of

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why health professionals have such a grave calling, and why they must abide by a much higher level of professionalism than those in other careers. Political appointments without any consideration of competence fail our patients and fail our country, and result in politics determining the ethics of healthcare – a moral pathology that must be eradicated for the ethical crisis that we find ourselves in to be comprehensively addressed.

1. Dhai A. After Life Esidimeni: True human rights protections or lip service to the Constitution? S Afr J Bioethics Law 2017;10(1):2-3. https://doi.org/10.7196/ sajbl.542 2. Makgoba MW. The Life Esidimeni disaster: The Makgoba report. PoliticsWeb. 1 February 2017. http://www.politicsweb.co.za/documents/the-life-esidimenidisaster-the-makgoba-report (accessed 10 July 2017). 3. South Africa. The Constitution of the Republic of South Africa, 1996. http://www. justice.gov.za/legislation/constitution/SAConstitution-web-eng.pdf (accessed 25 November 2017). 4. Department of Health, South Africa. The Ekurhuleni Declaration on Mental Health. April 2012. Appendix 3 of the National Mental Health Policy Framework and Strategic Plan 2013 - 2020. https://www.health-e.org.za/wp-content/ uploads/2014/10/National-Mental-Health-Policy-Framework-and-StrategicPlan-2013-2020.pdf (accessed 26 November 2017). 5. Oxford English Living Dictionaries. https://en.oxforddictionaries.com/definition/ experiment (accessed 25 November 2017).

S Afr J Bioethics Law 2017;10(2):40-41. DOI:10.7196/SAJBL.2017.v10i2.630

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

CORRESPONDENCE

Were ethical and legal issues violated, or was the book Mandela’s Last Days censored? Censorship ends in logical completeness when nobody is allowed to read any books except the books nobody can read (George Bernard Shaw) To the Editor: Nobel Peace Prize laureate Nelson Rolihlahla Mandela (Madiba) was the first black president of the Republic of South Africa (SA), the iconic figure of the liberation struggle against apartheid and the unique moral voice of the world.[1] Many books have been written about Madiba, including his own autobiography, Long Walk to Freedom,[2] but none has drawn more controversy than the recently published book, Mandela’s Last Days, authored by retired military doctor, Lieut. Gen. Vejay Ramlakan (VR).[3] According to the publisher’s author biography, VR has been a member of the African National Congress (ANC) for approximately 40 years, he was incarcerated on Robben Island from 1987 to 1991 and he was the surgeon general of the SA National Defence Force (SANDF) from 1995 to 2013.[3] He was charged with the responsibility of providing healthcare to Madiba from 2005 until his death on Thursday 5 December 2013.[3] His rationale for penning the book was to ‘recount one of the greatest triumphs of the human spirit and to set the record straight by rectifying the misconceptions, untruths, speculations and rumours about Mandela’s last years’.[3] Subsequently, VR has been accused of violating doctorpatient confidentiality by making Madiba’s medical records and treatment public without consent, and for making intimate personal disclosures about the Mandela family, thus violating their dignity, trust and respect.[4] In response, the publishers, Penguin Random House SA, without contestation and at their own expense, withdrew the book from bookstores countrywide within less than a month of its publication (June 2017), and all further sales of the book have been censored ‘out of respect for Madiba’s family’.[4] In his recent publication, McQuoid-Mason (MM)[6] details the ethical and legal principles that ought to be followed with regard to who should consent to disclosing the medical records and treatment protocols of a deceased public figure, and whether such disclosures are in the public interest. It is a legal requirement that all healthcare workers (HCWs) must be registered with the Health Professions Council of SA (HPCSA), a statutory body, in order to practise their profession. Citing the HPCSA’s ethical rules of conduct, MM states that ‘confidential information about a deceased patient should only be divulged with the written consent of his or her next of kin or the executor of his or her estate, failing which such information ought to be disclosed in terms of a statute or court order or the disclosure if justified in the public interest.’[6] Neither the HPCSA rule[6] nor the dictionary[7] provides a clear definition of next-of-kin. The latter defines next of kin as a ‘person’s closest living relative or relatives, next to 1. bedside, 2. following in order of importance’.[7] Who should consent in instances where there are family disagreements? Under such circumstances, MM submits that one should be guided by the National Health Act (NHA) No. 61 of 2003, which describes the order of persons who can give written consent on behalf of incompetent live patients or deceased persons to make public personal medical information and treatment.[6] The specific order of precedence is:

‘a spouse or partner, a parent, a grandparent, an adult or a brother or sister of the person.’[6] By this definition, Madiba’s widow, Graça Machel, has the legal authority to provide written consent, and not his ex-wife, Winnie Madikizela-Mandela, from whom Madiba was divorced (even though she was the only person at Madiba’s bedside as he drew his last breath),[3] nor the other categories of persons listed by the NHA.[6] VR has repeatedly claimed that he was given permission to pen the book at the request of the ‘family representative’ who gave approval.[3] The press recently reported that none among Graça Machel (Madiba’s widow), Winnie Madikizela-Mandela (his ex-wife), Mandla Mandela (his grandson), the executors of his estate and the Nelson Mandela Foundation, or the SANDF gave their consent.[4] To date the ‘family representative’ is known only to VR.[3] Although the law makes no distinction between oral and written consent, it is easier to prove written consent in the case of a dispute.[5] VR repeatedly reaffirms in the book that paramount in his mind when treating Madiba were ‘the requirements of doctor-patient confidentiality; state craft and state secrets; military protocol and the need for secrecy; addressing family anxieties; and ethical and legal considerations’.[3] Further, VR affirms that in consultation with a medicolegal expert, he was familiar with and adhered to the basic tenets of medical ethics applicable to healthcare (autonomy, beneficence, non-maleficence and justice). VR was also familiar with SA health legislation (presumably the NHA), which according to VR states that ‘a patient can, when well and lucid, give the power of informed consent to another person. If there is no mandate for this, then a spouse or partner, parent, grandparent, adult child or sibling (in that order) may take on the responsibility. Failing this, a court could make a ruling.’[3] VR argues that because Madiba was an iconic public figure, he (Madiba) had always been open about his health. In any event, much of Madiba’s medical information was already in the public domain in Long Walk to Freedom,[2] Nelson Mandela: Conversations with Myself,[8] Mandela: The Authorized Portrait[9] and in various other biographies about his life which VR quotes from and references in the book.[3] VR further contends that ‘Mandela appeared to view his health almost dispassionately, regarding it as a matter of public record [interest].’[3] Under such circumstances, it may be argued that doctor-patient confidentiality may not have been violated. However, VR chronologically documented Madiba’s new and deteriorating medical conditions and treatments with military precision during his last days, after Madiba retired from public office.[3] Because Madiba was no longer in public office, his privacy about his medical condition should have been respected, according to MM.[6] In addition, while the ‘information may be true, it should not have been published, because it is not necessarily material in which the public had an interest’.[6]

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CORRESPONDENCE VR had a longstanding relationship with Madiba and his family during the course of the liberation struggle and the years of incarceration on Robben Island, and as Madiba’s personal physician. Therefore, it is safe to assume that VR had the trust and confidence of Madiba and his family. This is borne out in the book by the military-like precision and tactics (sometimes covert) that VR and his ‘Charlie Team’ of HCWs employed to serve and protect Madiba and his family in the last days. Certainly no expenses (taxpayers’ monies) were spared. By his own admission, VR states that he obtained consent and that he was familiar with and adhered to the ethical and legal principles that were applicable and binding on him in providing adequate healthcare to his patient. The identity of the consentee/s remains unknown. Perhaps if VR had appended the signed consent document (if one exists) to the book, some of the controversies may have been resolved. Hundreds of controversial books, including unauthorised biographies, have been published under the iconic Penguin emblem. Several books on Madiba that contain his medical records and treatment are in the public domain. It is unlikely that each one of these books was authorised by the family. The accuracy of the book has not been questioned. However, according to MM, ‘the next of kin may sue in their personal capacity if they can prove that disclosures in the book were an unlawful invasion of their privacy.’[6] It is difficult to reconcile why the author, who was well versed in the ethical and legal requirements for the doctor-patient relationship, would allegedly violate these tenets. Post-apartheid SA no longer has censorship laws in place.[10] Perhaps a powerful and influential family was able to bring pressure to bear on the author and the publishers to withdraw the book from the marketplace.[11] By not allowing the book to be judged on its merit, removing the book is, in fact, tantamount to censorship.[11]

December 2017, Vol. 10, No. 2 SAJBL

M A Sathar Honorary Research Fellow, School of Law, University of KwaZulu-Natal, Durban, South Africa aslamsathar@ymail.com S Afr J Bioethics Law 2017;10(2):42-43. DOI:10.7196/SAJBL.2017. v10i2.608 1. Sathar MA. Mandela was the last of the truly moral leaders. Letters to the Editor. Durban: Sunday Tribune, 22 December 2013. 2. Mandela NR. Long Walk to Freedom: The Autobiography of Nelson Mandela. Johannesburg: Macdonald Purnell (Pty) Ltd, 1994. 3. Ramlakan V. Mandela’s Last Years. Johannesburg: Penguin Random House South Africa, June 2017. [publication withdrawn] 4. Drum Digital. Winnie Mandela breaks her silence on Mandela’s book. 27 July 2017. http://www.drum.co.za/news/winnie-mandela-breaks-her-silence-on-mandelasbook/ (accessed 19 August 2017). 5. Dada MA, McQuoid-Mason DJ. Introduction to Medico-Legal Practice. Durban: LexisNexis, 2001(5-32). 6. McQuoid-Mason DJ. Disclosing details about the medical treatment of a deceased public figure in a book: Who should have consented to the disclosures in Mandela’s Last Days? S Afr Med J (in press), 2017. 7. Soanes C, Hawker S (eds). Compact Oxford English Dictionary, 3rd Edition. Oxford: Oxford University Press, 2005. 8. Mandela NR, Nelson Mandela Foundation. Nelson Mandela: Conversations with Myself. London: Macmillan Publishers Ltd, 2010. 9. Parkin K (ed.). Mandela: The Authorised Portrait. Johannesburg: Wild Dog Press, in association with PQ Blackwell, 2006. 10. Merrett CP. Political censorship in South Africa: Aims and consequences. http:// www.sahistory.org.za/sites/default/files/DC/remar82.3/remar82.3.pdf (accessed 22 August 2017). 11. Le Roux L. The withdrawal of the Mandela book was nothing short of censorship. 15 August 2017. http://theconversation.com/the-withdrawal-of-the-mandelabook-was-nothing-short-of-censorship-82467 (accessed 18 August 2017).

Accepted 17 October 2017.

ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Life Esidimeni psychiatric patients in Gauteng Province, South Africa: Clinicians’ voices and activism – an ongoing, but submerged narrative B Janse van Rensburg, MB ChB, FCPsych(SA), MMed, PhD Department of Psychiatry, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; President, South African Society of Psychiatrists (2016 - 2018) Corresponding author: B Janse van Rensburg (albert.jansevanrensburg@wits.ac.za)

After the first 45 days and beyond, the Life Esidimeni (LE) debacle may be slipping from public awareness. Despite ample evidence of clinicians’ attempts to communicate their concern about this, as well as active steps to try to prevent it prior to the termination of the contract with LE, the question to South African doctors of ‘What have you been doing about this?’ has again been raised by some role players. This made it necessary to consider the notion of a ‘submerged clinicians’ narrative’ in terms of the facts regarding: (i) the actual involvement of individual clinicians and professional societies collectively; (ii) individual doctors’ responsibility as clinical decision-makers; (iii) other examples of clinicians’ ongoing and repeating narrative; and (iv) possible conflict of interest between clinicians’ relationships with their patients, and as employees, with a third party, whether a state or private employer or funder. Considering the evidence available, it does seem that despite a sustained level of communication and action by clinicians, and in particular by psychiatrists, on this matter, their communication and activism largely remained submerged, and as such, outside of public awareness and acknowledgement by politicians and managers, who were in all instances the final decision-makers on clinical matters pertaining to these patients. S Afr J Bioethics Law 2017;10(2):44-47. DOI:10.7196/SAJBL.2017.v10i2.614

Having passed the first 45-day benchmark, as well as the extended period granted to the end of May 2017, after the release of the health ombudsperson’s report,[1] the Life Esidimeni (LE) debacle may be slipping from public awareness. The report included several recommendations, including numbers 11 and 13 (pages 54 - 55),[1] which required that all patients still residing in listed illegal non-governmental organisations (NGOs) must be moved back to suitable locations. When this process started early in February 2017, one of the psychiatrists attending the meeting was asked what she, as a clinician, had personally done to prevent the moving of these patients from LE. What made this question unexpectedly ironical was that it was asked of the doctor who, as the convener of the public sector group of the South African Society of Psychiatrists (SASOP), had in April 2015 already actually focused the initial communication between clinicians and decision-makers on possible alternatives to the decision to terminate the LE contract. She had also, as a director of SASOP’s board, supported the uniform decision in December 2015 that SASOP should engage, with others and led by Section 27, in the legal action against the Gauteng Department of Health (GDoH). This was unusual, as it represented the first incident where this body of professionals took a state department, as its employer, to court, in order to oppose such a unilateral decision. The first court hearing resulted in a recommendation to settle differences outside of court by the end of January 2016, with the GDoH agreeing that the same level of care would be ensured for LE patients, if moved. This settlement did not happen though, owing

to failure by the GDoH to produce additional information on the process. However, when it was realised that the first patients were being moved, Section 27 returned to court in March 2016, to apply for an interdict to prevent this. The GDoH was, however, able to convince the court that they were still honouring the original agreement, and the application was dismissed. The GDoH proceeded with their now infamous ‘marathon project’ in arrogance, and in particular, with specific disregard for the opinions of individual and collective clinicians, several of whom were also employed by the GDoH. This included the doctor referred to above, faced with the question about her personal involvement. This same doctor was subsequently invited to join the health ombud’s expert panel, appointed in October 2016, to investigate the first reported deaths of patients, and as a main contributor, she concluded the panel’s reporting back to the ombud in November 2016. The final component of the irony of this question being asked of this doctor was that it was in fact posed by the national minister of health, Dr Aaron Motsoaledi himself, who also appointed her on departmental task teams to remove the LE patients from NGOs, but apparently was not aware of either this colleague’s particular personal track record, or of SASOP’s collective involvement in the whole LE saga since its beginning.

Discussion To consider the notion that the clinicians’ narrative regularly remains ‘submerged’ in this and similar situations, it is important to look at

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ARTICLE the facts regarding: (i) the actual involvement in the LE incident of individual clinicians and professional societies collectively; (ii) individual doctors’ responsibility as clinical decision-makers; (iii) other examples of clinicians’ ongoing and repeating narratives; and (iv) possible conflict of interest in clinicians’ relationships with their patients as employees of a third party, be it in the state or private healthcare system.

Other groups of concerned clinicians, represented by Rural Rehab South Africa, People’s Health Movement SA, the Treatment Action Campaign (TAC), the Public Health Association of SA’s Mental Health Special Interest Group and SAMA’s Junior Doctors Association of SA (JUDASA) also issued statements of concern and open letters during September and October 2016, insisting on answers from the Gauteng MEC at the time.[6,7]

Clinicians’ voices in the LE incident, individually and collectively

Gauteng clinicians’ communication through line-function channels During April 2015, through a memorandum to the director of the Gauteng Directorate of Mental Health, the different clinical heads of the three specialised hospitals in Gauteng, more than 10 heads of psychiatric departments and units in other Gauteng hospitals, as well as the academic heads of psychiatry departments at the University of the Witwatersrand, the University of Pretoria and Sefako Makgatho University sought an appointment with the Gauteng MEC to express concern about the plan. Several GDoH managers were copied in this letter, including the chief director for planning and the chief financial officer. During July 2015, clinicians reported on the state of affairs regarding mental-healthcare services in the Charlotte Maxeke Johannesburg Academic-Hospitals (CMJAH) cluster.[8] Subsequently, ongoing problems have been pointed out in communications between clinicians and their respective executive managers at different hospitals, such as South Rand, Helen Joseph, Chris Hani-Baragwanath Academic and CMJAH. There seems to be a specific manner in which communication by clinicians through the line-function channels available to them gets submerged – by inadvertently dropping mental-healthcare issues from agendas, priority lists and funding, and omitting them from forums where opportunities might arise to resolve these challenges in a systematic way.

Judged from this individual psychiatrist’s quoted experience, it appears as if the role that clinicians in general, and psychiatrists in particular, played in the LE matter has indeed been submerged throughout this ongoing process of more than 18 months, and therefore has also escaped the awareness of other role players. Despite documented evidence of clinicians’ attempts to communicate their concern, as referred to by the health ombud’s report,[1] the question to South African (SA) clinicians as to ‘What have you been doing?’ has indeed also been asked by SASOP’s own members, by the World Psychiatric Association (WPA), as well as possibly by the public and others. SASOP’s involvement: Psychiatry’s and psychiatrists’ social contract SASOP’s involvement in the LE incident included alerting the South African Depression and Anxiety Group (SADAG) and requesting their involvement in September 2015; arranging consultative meetings with role players in SASOP’s adopted programme of the psychiatry and psychiatrists’ social contract,[2, 3] including different advocacy groups, in August 2015, and professional societies involved in the multidisciplinary team in October 2015; issuing a position statement on the closure of LE in December 2015, prior to being a respondent in the court action undertaken to prevent the transfer of patients without a proper plan, in March 2016; several individual SASOP and SASOP board members’ personal participation in the health ombud’s investigation in October and November 2016; and individual members’ efforts, in a linefunction capacity, to deal with the daily increased demand on additional services. The South African Medical Association (SAMA) SAMA released two media statements, one in September 2016 following input from its Human Rights, Law and Ethics Committee before the SAMA National Council,[4,5] and the second in February 2017 following the release of the health ombud’s report. SAMA condemned the GDoH for ignoring the concerns that had been expressed by representatives of the medical and psychiatric fraternity, and in particular, by SASOP, South African Depression and Anxiety Group (SADAG) and the South African Mental Health Federation (SAMHF). Other professional groups In a letter dated 18 January 2016, the Psychological Society of South Africa (PsySSA) forwarded written concerns to the then-Gauteng Member of the Executive Council (MEC) for health about the planned closure of the LE facilities.

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Faculties of health sciences While the Faculty of Health Sciences at the University of the Witwatersrand (Wits) only discussed the matter internally at their faculty board meeting in February 2017, the Faculty of Medicine and Health Sciences of SU issued a public press statement, signed by several members of the deanery and executive HODs.[9] Similarly to the previous Gauteng health MEC, who denied that she had ever received the letter from SASOP, or a follow-up letter in October 2015, it was also reported that the premier of Gauteng, Mr David Makhura, stated that he was unaware of a letter from the Wits class of 2016 occupational therapy students, appealing to authorities not to close Waverley Care Centre.[10,11]

Individual doctors’ responsibilities as clinical decision-makers There are two matters regarding individual doctors’ actions and responsibilities reported on in the health ombud’s report that must also be further explored. The first is the content included in paragraph 4.1.5 of the report as ‘The voices of LE staff’ (pages 8 - 9), and the second pertains to a statement made by the Gauteng MEC of Health at the time, with regard to advice she received from psychiatrists (pages 15 -16).[1]

ARTICLE LE staff From their statements to the health ombud, the medical practitioners employed by LE at the time noted that they were ‘not comfortable’ with the decision: one doctor resigned out of conscience; the others were ‘trying their best under trying circumstances and against their consciences and better judgements’, while ‘not having a choice’. They also referred to the chaotic transfer process. The question as to whether doctors at LE discharged or transferred patients alludes back to a dismissed interdict application in March 2016, where the presiding judge commented on the distinction that must be drawn between the ‘discharge’ and ‘placement’ of mental healthcare users. He noted that users are only ‘discharged’ once they have been assessed by a ‘qualified professional’, deemed fit to be cared for by their family and no longer in need of services, while mental health care users are transferred as a ‘placement’, on the basis of a determination that they remain in need of services.[12] It can be concluded that it is very unlikely that these doctors would have thought that all these long-term patients’ mentalhealth status had suddenly changed from requiring ‘assisted’ mental healthcare for several years, to that of ‘voluntary’ healthcare users, who have somehow overnight regained their capacity to make informed decisions. Also, any ‘discharging’ of patients that might have happened only occurred with the assurance from GDoH officials that they would be transferred to equivalent care facilities. Advising psychiatrists The previous health MEC reported to the health ombud that she was advised ‘by Dr Sokudela and Dr Madigoe’ that ‘patients need to be discharged in phases’ (page 15).[1] She also argued that ‘in all meetings none of the psychiatrists raised these concerns (about moving patients too rapidly) with her’ (page 16).[1] One has to assume that she still referred here to Drs Sokudela and Madigoe, as she never met with SASOP during this period. She only requested a meeting with SASOP after critical reports were received about her not meeting with professionals with opposing views. It may therefore be necessary to further explore how these named colleagues actually advised the MEC and others of the GDoH at the time.

Other examples of clinicians’ ongoing, repeating narratives and tasks Reflecting on other historic examples of where clinicians’ voices and activism might have been ongoing, but submerged, the following come to mind: • The apartheid era and Steve Biko: In this first example, the submerging of clinicians’ narratives required the irrational component of white supremacy as an ingredient, with the official and public approach acquiring a specific denialist and delusional quality.[13,14] • The AIDS and antiretroviral denial period during the 1990s: In a similarly irrational manner, in this instance an African traditional alternative approach, flying in the face of medical knowledge, was opposed by many groups of clinicians at the time. Overy[15] describes the different strategies that the TAC followed in its ongoing campaigns for access to antiretroviral (ARV)-treatment, including litigation via the courts. One such case was about the right of access to public health services, and children’s right to be afforded special protection,[16] as considered by the

Constitutional Court.[17,18] Jobson[19] refers to Dr Colin Pfaff who, in 2007, implemented the knowledge that dual therapy is superior to monotherapy in prevention of mother-to-child transmission of HIV in reducing viral transmission rates, in mothers 28 weeks pregnant in rural KwaZulu-Natal, prior to its subsequent acceptance as a treatment guideline. He was charged at the time with misconduct and acting unlawfully, despite of support by the Rural Doctors’ Association of SA and the SA HIV Clinicians’ Society. • Stigma and poor prioritisation of mental healthcare: Ahmedani[20] comments that mental-health stigma operates in society, is internalised by individuals and is contributed to by health professionals, while Sartorius[21] notes that stigma makes even community and health decision-makers hold people with mental illness in low regard, resulting in their reluctance to invest resources into mental healthcare. The stated core incentive of the GDoH to move patients from LE to ‘save money’ has been pursued with such disregard for the basic needs and human rights of mental healthcare users that it can be regarded as having assumed a similar irrational quality to the two historical examples above, where contact was indeed lost with what should have been a reasonable approach to mental healthcare prioritisation.

Dual loyalties and human rights On the question of whether clinicians’ voices and activism have become a submerged narrative as far the LE psychiatric patients are concerned, one is reminded of the group Physicians for Human Rights and the School of Public Health and Primary Health Care at the University of Cape Town (PHR, and SPH and PHC). They have produced a comprehensive report and guide on the need for clinicians to take decisive action in cases of human-rights abuses of their patients.[22] In Chapter V[22] of their guide, they identify several institutional mechanisms through which to promote human rights by stakeholders, including national professional organisations (e.g. SASOP); international professional organisations (e.g. WPA); statutory bodies; civil society; government itself; and training and research institutions.[22] With regard to the proposed activities that national professional organisations should be considering, PHR, and SPH and PHC list a number of actions to be taken. Considering this list in the context of the LE experience, and noting the pre-empting at the time of the subsequently appointed health ombudsperson, several of these were pursued in this matter by different individual clinicians and professional groups. Institutional mechanisms to promote human rights that national professional organisations should undertake to implement[22] ‘(1) Establish professional practice standards that address the problem of dual loyalty and human rights for across a wide spectrum of practice settings and situations; (2) Where violations of professional standards take place, hold members accountable to these standards through appropriate disciplinary action; (3) Facilitate adoption of selfaudits by health services to complement application of standards. Special audits can be commissioned in various settings; (4) Make available advisers and counsellors skilled in human rights and ethics to health professionals practising in circumstances where problems of dual loyalty and human rights arise; (5) Provide direct support for health professionals in high-risk situations, (e.g. prison healthcare,

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ARTICLE occupational health, military medicine) under the auspices of the professional association; (6) Establish or facilitate an independent oversight and reporting structure to play a monitoring and/or ombudsman role; (7) Issue newsletters and create websites to raise awareness in the professions and the public, and conduct ongoing debate on dual-loyalty problems in a range of vehicles, such as journals and professional meetings; (8) Initiate and support ongoing ethical and human-rights training that addresses the problem of dual loyalty and human rights; (9) Ensure that constitutions of national professional organisations establish the organisation as independent of the state and of state policy; (10) Submit shadow reports on national reports to United Nations treaty-monitoring bodies for human-rights treaties such as the Convention Against Torture and the Covenants on Civil and Political Rights and Economic, Social and Cultural Rights on issues concerning dual loyalty and human rights; (11) Advocate for legal, administrative and social changes that will enable health professionals to respect, protect and fulfil the human rights of their patients; (12) To implement many of the above mechanisms, national associations may have to develop plans and invest resources to increase members’ support for these organisational actions.’[22]

Conclusion Despite an unprecedented and sustained level of communication by clinicians on this matter, it still seems, however, that clinicians’ communication and activism in this regard did remain largely submerged and, as such, stayed outside of public consciousness and of the official awareness of the politicians and managers, who were the final decision-makers on such clinical matters. Acknowledgements. Prof. Laurel Baldwin-Ragaven, Department of Family Medicine, University of the Witwatersrand, regarding information about the Physicians for Human Rights and School of Public Health and Primary Health Care at the University of Cape Town. Author contributions. Sole author. Funding. None. Conflicts of interest. None.

1. Office of Health Standards Compliance. Health ombudsperson report into the ‘Circumstances surrounding the death of mentally ill patients: Gauteng Province’. http://ohsc.org.za/wp-content/uploads/2017/09/FINALREPORT.pdf (accessed 26 February 2017). 2. Bhugra D. Introduction. In: Bhugra D, Malik A, Ikkos G (eds.). Psychiatry’s Contract with Society: Concepts, controversies and consequences. Oxford: Oxford University Press, 2011:59-72. 3. Cruess SR. Professionalism and medicine’s social contract with society. Clin Orthop Relat Res 2006;449:170-176. 4. South African Medical Association. Newsletter: South African Medical Association calls for the resignation of the Gauteng MEC, condemns transfer of patients, calls for action to prevent more deaths. https://www.samedical.org/cms_uploader/ viewArticle/369 (accessed 26 February 2017).

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5. South African Medical Association. Media Release: Gauteng Health MEC must still be held accountable despite resignation. https://www.samedical.org/cms_ uploader/viewArticle/406 (accessed 26 February 2017). 6. Times Live. Death of psychiatric patients was a violation of constitutional dispensation – open letter to Gauteng Health MEC. 27 September, 2016. http:// www.timeslive.co.za/local/2016/09/27/%E2%80%98Death-of-psychiatricpatients-was-a-violation-of-constitutional-dispensation%E2%80%99-%E2%80 (accessed 20 March 2017). 7. Khan-Gillmore S. Open letter to Minister Motsoaledi: Muzzling healthcare workers does little to address problems in the system. Daily Maverick. 10 March 2017. https://www.dailymaverick.co.za/article/2017-03-10-open-letter-to-ministermotsoaledi-muzzling-healthcare-workers-does-little-to-address-problemsin-the-system?utm_source=8bit&utm_medium=internal#.WMI7MW9973g (accessed 12 March 2017). 8. Janse van Rensburg B, Baldwin-Ragaven L. Internal Report (unpublished). CMJAH [Charlotte Maxeke Johannesburg Academic Hospital] Cluster Investigation of the Coordination of Psychiatric Services with Regard to 72-Hour Assessment. Wits [University of the Witwatersrand] Departments of Psychiatry and Family Medicine, February 2015. 9. Faculty of Medicine and Health Sciences Marketing Office. Stellenbosch University FMHS. Where is the care in our health care system? http://www.sun. ac.za/english/Lists/news/DispForm.aspx?ID=4649 (accessed 10 February 2017) 10. News 24. Makhura never saw Esidimeni warning letter – official. 12 February 2017. http://www.news24.com/SouthAfrica/News/makhura-never-saw-esidimeniwarning-letter-official-20170212 (accessed 26 February 2017). 11. Class of 2016 Occupational Students. Letter regarding the closing of Waverley Care Centre in Germiston. http://www.politicsweb.co.za/documents/lifeesidimeni-the-wits-students-warning-to-makhur (accessed 26 February 2017). 12. South African Depression and Anxiety Group and others v MEC of Health, Gauteng and others. Gauteng High Court Johannesburg Local Division 14 March 2016. Case no. 08904/16. 13. Kentridge, S. Evil under the sun: The death of Steve Biko. The 12th Annual Steve Biko Memorial Lecture Delivered on 12 September 2011. Advocate December 2011;24(3):32-36. 14. Pityana NB. The legacy of Steve Biko. In: Bounds of Possibility: The Legacy of Steve Biko and Black Consciousness. N. Barney Pityana, Mamphela Ramphele, Malusi Mpumlwana, and Lindy Wilson (eds). Cape Town: Zed, 1991. 15. Overy N. In the face of crisis: The Treatment Action Campaign fights government inertia with budget advocacy and litigation. International Budget Partnerships. From Analysis to Impact. Partnership Initiative Case Study Series. Study No. 7, August 2011. https://www.internationalbudget.org/wp-content/uploads/LPcase-study-TAC.pdf (accessed 26 February 2017). 16. Minister of Health and others v Treatment Action Campaign 2002 (5) SA 721 CC. 17. Baimu E. The government's obligation to provide anti-retrovirals to HIV-positive pregnant women in an African human rights context: The South African nevirapine case. Afr Hum Rights Law J 2002;1:160-174. 18. Heywood M. Preventing mother-to-child HIV transmission in South Africa: Background, strategies and outcomes of the Treatment Action Campaign case against the Minister of Health. S Afr J Hum Rights 2003(19):278-315. 19. Jobson R. Why I am not a rural doctor. Johannesburg: Mail & Guardian, 19 February 2008. http://thoughtleader.co.za/royjobson/2008/02/19/why-i-amnot-a-rural-doctor/ (accessed 20 March 2017). 20. Ahmedani BK. Mental health stigma: Society, individuals, and the profession. J Soc Work Values Ethics 2011;8(2):4-1 - 4-16. 21. Sartorius N. Stigma and mental health. Lancet 2007;370(9590):810-811. https:// doi.org/10.1016/S0140-6736(07)61245-8 22. Physicians for Human Rights and School of Public Health and Primary Health Care, University of Cape Town. Dual Loyalties and Human Rights in Health Professional Practice, 2002. https://s3.amazonaws.com/PHR_Reports/dualloyalties-2002report.pdf (accessed 26 February 2017).

Accepted 17 October 2017.

SHORT REPORT

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Following on from the Life Esidimeni incident – access to care for people living with severe mental disability, according to national policy B Janse van Rensburg, MB ChB, FCPsych(SA), MMed, PhD Department of Psychiatry, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg; President, South African Society of Psychiatrists (2016 - 2018) Corresponding author: B Janse van Rensburg (albert.jansevanrensburg@wits.ac.za)

Following the release in February 2017 of the health ombudsman’s report on the deaths of psychiatric patients in Gauteng Province, South Africa (SA) (the Life Esidimeni incident), the South African Society of Psychiatrists (SASOP) has called for a complete overhaul of the mentalhealthcare system in terms of the principles of existing mental-health policy, in particular the National Mental Health Policy Framework and Strategic Plan 2013 - 2020 (NMHPF and SP). Overhauling the mental-healthcare system according to the NMHPF and SP will include the identification and costing of the required facility and staffing interventions that must be put into place to ensure capacity and integration on the different service levels, namely: residential and day-care community-based facilities and programmes, providing a range of care, treatment and rehabilitation services with a fulltime multidisciplinary team available; primary mental-healthcare services at district level; a specialist community-psychiatry service; acute psychiatric units in secondary, tertiary and central general hospitals; and specialised psychiatric beds. S Afr J Bioethics Law 2017;10(2):48-51. DOI:10.7196/SAJBL.2017.v10i2.615

According to the NMHPF and SP (Table 1),[3] provincial departments of health will license and regulate the provision of community-based mental-health services by non-governmental organisations (NGOs) and for-profit organisations, such as community residential care, daycare services, and halfway houses.

FREQUENCY OF NEED

COSTS

Residential and day-care community-based facilities and programmes

Psychiatric services Community in general mental-health hospitals services

Primary-care services for mental health

Informal community care

ARE

This involves the integration of services on the different levels (Fig. 1),[3} namely: (i) residential and day-care community-based facilities and programmes, providing a range of care, treatment and rehabilitation services with a full-time multidisciplinary team; (ii) primary mentalhealthcare services in districts; (iii) specialist community psychiatry service; (iv) acute psychiatric inpatient units in secondary, tertiary and central general hospitals; and (v) specialised psychiatric beds.

Long-stay facilities and specialist psychiatric services

F-C

Discussion

HIGH

LOW

SEL

Following on from the Life Esidimeni tragedy, where more than 100 psychiatric patients died because of a poorly planned de-institutionalisation project implemented by the Gauteng Department of Health (GDoH), and in view of ongoing pressures on the mental healthcare delivery system in Gauteng Province and elsewhere, the South African Society of Psychiatrists (SASOP) called in February 2017, and again in June 2017, for a complete overhaul of the mentalhealthcare system.[1,2] It was noted in these SASOP statements that such an overhaul should be considered in terms of the principles of existing mental-health policy, in particular the National Mental Health Policy Framework and Strategic Plan 2013 - 2020 (NMHPF and SP).[3]

Self-care

HIGH

QUANTITY OF SERVICES NEEDED

LOW

Fig. 1. Organisation of services in the National Mental Health Policy Framework and Strategic Plan 2013 - 2020.[3]

Primary mental-healthcare services in districts This represents the first level of contact for individuals seeking healthcare in terms of the NMHPF and SP (p8).[3] Primary clinical psychiatric care may include the management of mild depression

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SHORT REPORT Table 1. Residential and day-care community-based facilities and programmes: Definitions and terms according to NMHPF and SP[3] Primary healthcare (PHC) and primary-level services (page 8) PHC: Essential healthcare is to be made accessible at a cost the country and community can afford, with methods that are practical, scientifically sound and socially acceptable (Alma Ata Declaration, 1978). This approach is organised to reduce exclusion and social disparities in health, is people-centred, intersectoral and collaborative, and promotes the participation of all stakeholders. Primary-level services: The first level of contact for individuals seeking healthcare.

Community mental-health services (page 23) These will be scaled up, to match recommended national norms, and will include three core components: (i) community residential care (including assisted living and group homes); (ii) day-care services; and (iii) outpatient services (including general health outpatient services in PHC and specialist mental-health support). These community mental-health services will be developed before further downscaling of psychiatric hospitals can proceed. In accordance with MHCA, NGOs and voluntary and consumer organisations will be eligible to provide and be funded for community programmes/facilities. This includes capacity development for users (service users and their families) to provide appropriate self-help and peerled services, for example as community health workers.

Table 2. Primary mental-healthcare services in districts: Definitions and terms according to NMHPF and SP[3] The district mental-health system will be strengthened in the following areas (page 23): (i) Specified mental-health interventions will be included in the core package of district health services, embracing a task-shifting approach whereby trained non-specialist workers deliver evidence-based psychosocial interventions. These should include medication monitoring and psychosocial rehabilitation within a recovery framework for severe mental illness; detection and a stepped approach to management and referral of depression and anxiety disorders in PHC clinics; detection and management of child and adolescent mental disorders in PHC clinics and at community level (e.g. schools), and referral where appropriate; routine screening for mental illness during pregnancy; and a stepped approach to management and referral. (ii) Mental-health training programmes for general health staff will be conducted at PHC level and district and regional hospitals. (iii) Supervision systems will be put in place for mental-health staff at PHC level. (iv) Specialist mental-health teams will be established to support non-specialist PHC staff and community-based workers. (v) Clinical protocols will be available for assessment and interventions at PHC level, through integrated management guidelines, which will include mental health. (vi) Community-based rehabilitation programmes will be established in all districts, using a task-shifting approach. (viii) Mechanisms will be developed for intersectoral collaboration for mental health, led by the health sector and engaging a range of other sectors. (ix) Inpatient units will be built in district and regional hospitals. (x) Voluntary mental-healthcare users who require admission will be admitted in terms of general health legislation. (xi) Assisted and involuntary mental-healthcare users will be admitted in terms of the provisions and procedures described in the MHCA as emergency admissions, or for 72-hour assessment in facilities that are listed for this purpose. Further care, treatment and rehabilitation of such users will be provided at health establishments designated for this purpose in terms of the MHCA. Roles and responsibilities of district health services (page 31) (i) Providing mental-health promotion and prevention interventions, in keeping with national and provincial priorities; (ii) inclusion of mental health in the core package of district health treatment and rehabilitation services (e.g. routine screening for mental illness during pregnancy, and provision of counselling and referral where appropriate; medication monitoring and psychosocial rehabilitation within a recovery framework for severe mental illness; detection of mental illness and management of common mental disorders such as depression and anxiety disorders in PHC clinics, and referral where appropriate; and detection and management of child and adolescent mental disorders in PHC clinics, and referral where appropriate; (iii) providing 24-hour emergency care and 72-hour observation services in designated district and regional hospital inpatient settings, as set out in the MHCA; (iv) conducting mental-health training programmes for all general health staff for basic screening, detection and treatment, as well as referral of complex cases; (v) establishing and maintaining mental-health supervision systems for health staff at PHC level; (vi) establishing and maintaining specialist mental-health teams to support PHC staff; (vii) establishing and maintaining referral and back-referral pathways for mental health; (viii) implementing clinical protocols for assessment and interventions at PHC level; (ix) establishing and maintaining community-based rehabilitation programmes, through trained community health workers; (x) developing intersectoral collaboration between a range of sectors involved in mental health, through the establishment of district multisectoral forums for mental health; (xi) undertaking mentalhealth education programmes in communities; (xii) improving the capacity of district health management teams for planning, implementing, supervising, monitoring and evaluation of mental-health programmes at district and community levels; and (xiii) providing of psychotropic medication to all appropriate levels of the district health system, as determined by the essential drugs list. PHC = primary healthcare.

and anxiety, the maintenance of stabilised psychotic conditions and of substance use and abuse, including intoxication and followup of psychosis/mood problems related to substances, as well as adjustment disorders. Primary care, level-I district hospitals and family-medicine specialists in the district are described accordingly in the NMHPF and SP (Table 2).

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Specialist community-psychiatry services in the district District specialist mental-health teams consist of a psychiatrist, psychologist, occupational therapist, specialist professional nurse and social worker. For terms of reference, refer to NMHPF and SP (Table 3).

SHORT REPORT Table 3. Specialist community-psychiatry services in the district: Definitions and terms according to NMHPF and SP[3] Specialist community psychiatry service in the district, terms of reference (Appendix 1, page 41) (i) Adopt a public-health approach to the mental health of the district, conducting a situation analysis of mental-health needs and service resources in the district population, and developing an action plan for promotion, prevention, treatment and recovery. (ii) Establish routine ongoing training and supervision for PHC staff through the district specialist mental-health team. Establish routine referral pathways from primary care to specialist services in each district. (iii) Introduce routine indicated assessment and management of common mental disorders (depression, anxiety and alcoholuse disorders) in priority programmes at PHC level: TB; HIV/AIDS; antenatal mothers; postnatal care; family planning; and chronic diseases. (iv) Embed suicide prevention in treatment at PHC level, through identification of risk factors for suicide in all health-service provision. (v) Strengthen school systems for mental-health promotion, prevention of mental illness, detection and management of child and adolescent mental disorders in schools, and referral where appropriate, in line with the School Health Policy. (vi) Establish posts for psychologists in community settings, and look for opportunities for psychologists in psychiatric hospital settings to move to community settings. (vii) Provide clinical and consultation liaison services within the district. (viii) Encourage the implementation of the Traditional Health Practitioners Act No. 22 of 2007, by facilitating links between mental-health services and traditional healers and faith healers at local district levels, including appropriate referral pathways in both directions. (ix) Deploy intern psychologists and registered counsellors to provide training, supervision and support for the counselling roles of community health workers. (x) Build capacity for users (service users and their families) to provide appropriate self-help and peer-led services, such as support groups, facilitated by NGOs.

Acute psychiatric units in secondary, tertiary and central general hospitals Psychiatric services/units in general hospitals render specialist levels of services back-to-back with community psychiatric health services (TableÂ 4). According to the Mental Health Care Act No. 17 of 2002 (MHCA), 72-hour assessment services are also rendered in general hospitals, including district hospitals providing primary care service level. â&#x20AC;˘ Secondary hospitals. While secondary clinical psychiatric care may include routine maintenance and review of psychiatric conditions, such as mood, psychotic, anxiety, cognitive and other disorders, a regional hospital provides identified specialist services, including psychiatry on a 24-hour basis, and a defined regional drainage population within provincial boundaries. They have 400 - 800 beds.[4] It also receives outreach from tertiary hospitals. â&#x20AC;˘ Tertiary and central hospitals. Tertiary clinical psychiatric care includes: treatment-resistant conditions; the failure of first and second line of treatment; medical comorbidity requiring liaison with other specialists or subspecialists, e.g. cardiovascular instability, thyroid abnormality, rheumatology, neurology, pain,

Table 4. Acute psychiatric units in secondary, tertiary and central general hospitals: Definitions and terms according to NMHPF and SP[3] Secondary and tertiary care (Glossary, page 8) Secondary care: Specialist care that is typically rendered in a hospital setting following a referral from a primary or community health facility. Tertiary care: Specialist care that is rendered at central hospitals. Psychiatric services in general hospitals (page 24) (i) Inpatient units will be provided in general hospitals to improve access for voluntary admission, assisted care, emergency mentalhealth services, 72-hour assessment of involuntary mentalhealthcare users, further care, treatment and rehabilitation. (ii) Voluntary mental healthcare users who require admission will be admitted in terms of general health legislation. (iii) The psychiatric wards that are attached to general hospitals must be designated in terms of the MHCA where they meet the criteria. (iv) The general hospitals that provide 72-hour assessment for involuntary mental healthcare must be listed as prescribed in the general regulations of the MHCA. (v) Information regarding health establishments that provide 72-hour assessment for involuntary mental healthcare must be compiled and provided to relevant stakeholders to facilitate referral and access to services. MHCA = Mental Health Care Act No. 17 of 2002.

and obstetrics and gynaecology; psychiatric subspecialty areas in a hospital setting; and psychotherapy in a specialist hospital setting. A tertiary hospital provides specialist and subspecialist services, and has 400 - 800 beds.[4] A central hospital provides tertiary and central referral services, and highly specialised and super-specialised national referral units. It has 1 200 or more beds, while both tertiary and central hospitals provide training attached to a medical school, and also conduct research.[4]

Specialised psychiatric beds The definition of a specialised hospital is a facility that provides psychiatry, tuberculosis, infectious diseases or rehabilitation services, and has 600 or more beds.[4] The care provided in specialised psychiatric hospitals and rehabilitation centres is described in the NMHPF and SP (Table 5).

Conclusion The NMHPF and SP, with its eight objectives, resulted from the allimportant national summit on mental health, held in April 2012, and the associated Ekurhuleni Declaration on Mental Health (Appendix 3 of the NMHPF and SP, pp 48 - 51).[3] SASOP commended this policy document at the time, and has commented in detail on its different components.[5] While the GDoH, with the decision to terminate its contract with Life Esidimeni, has allowed all the principles of these commitments to be ignored, there are renewed calls to provinces to ensure the actual implementation of this policy in Gauteng and elsewhere and to urgently translate it into practical action plans, with enabling budgets to fund the required facilities and staffing. In terms of the strategic action to take, the way forward would include the tasks listed below. (i) Organisation and management: Management forums designated to mental health and psychiatry must be established for tertiary and central-hospital drainage areas, and between levels of service.

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SHORT REPORT Table 5. Specialised psychiatric beds: Definitions and terms according NMHPF and SP[3] Specialised (designated) psychiatric hospitals and rehabilitation centres (pages 24 and 32) (i) Provide further care, treatment and rehabilitation of mental healthcare users in specialised psychiatric hospitals. (ii) Provide inpatient and limited outpatient mental-health services. (iii) Function as centres of excellence that provide ongoing routine training, supervision and support to secondary and PHC services. (iv) Provide subspecialist services, such as forensic psychiatry and child and adolescent services. (v) Enable forensic facilities to fulfil their role as set out in the Criminal Procedure Act No. 51 of 1977 as amended, with regards to forensic psychiatric observations. Sections 41 and 49 of the MHCA provide for the designation of health establishments and procedures with regards to state patients and mentally ill prisoners. PHC = primary healthcare; MHCA = Mental Health Care Act No. 17 of 2002.

(ii) Facilities: Facilities on the different levels must be brought up to an acceptable standard, including identified projects at acute specialist units as well as others, such as 72-hour assessment facilities at district hospitals. (iii) Human resources: Core posts must be identified to allow for the appointment of adequate staff on the different levels.

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(iv) Budget review and strategic planning: The proportion of the health budget that is available for mental healthcare must be identified, with a view to following 1- and 5-year strategic planning cycles. (v) Implementation task teams and workshops: Provincial task teams must be appointed to operationalise and implement national mental-healthcare policy in terms of the NMHPF and SP.

1. South African Society of Psychiatrists (SASOP) Media Statement. Call for Complete Overhaul of Mental Health Care System. https://www.sasop.co.za/Content/ Images/StatementHealthOmbud_LE4Feb2017.pdf (accessed 8 February 2017). 2. South African Society of Psychiatrists (SASOP) Media Statement. Call for Access to Care for People Living with Severe Mental Disability. https://www.sasop.co.za/ Content/images/SASOPSTATEMENTPressRelease.pdf (accessed 28 June 2017). 3. National Department of Health. National Mental Health Policy Framework and Strategic Plan 2013 - 2020. Pretoria: NDoH, 2013. https://www.health-e.org.za/ wp-content/uploads/2014/10/National-Mental-Health-Policy-Framework-andStrategic-Plan-2013-2020.pdf (accessed 3 June 2017). 4. Regulations relating to categories of hospitals. Government Gazette, 12 August 2011, R655. 5. Janse van Rensburg ABR. Contributions from the South African Society of Psychiatrists (SASOP) to the National Mental Health Action Plan. S Afr J Psych 2013;19(4):205-212. https://doi.org10.7196/SAJP.501

Accepted 17 October 2017.

REVIEW

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

The Life Esidimeni tragedy: A human-rights perspective B A Ferlito, BPH, BHSc (Honours); A Dhai, PhD, MB ChB, FCOG, LLM, PG Dip (Int Res Ethics) Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: A Dhai (ames.dhai@wits.ac.za)

The International Covenant on Economic, Social and Cultural Rights (ICESCR) affirms that all human beings are entitled to core rights essential to human fulfilment. Although all human rights are important, the ICESCR’s guarantee of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health may be the most significant. Having good health is necessary for human wellbeing. Paramount to this is the freedom of individuals to exercise their human rights. As seen with the Life Esidimeni tragedy, people with mental illnesses often find it more difficult than others to achieve the fulfilment of their rights. This article discusses human-rights legal instruments, and focuses on the rights to health, life and dignity in the context of the tragedy. It also examines how the realisation of human rights can have meaningful results for mentally ill people. S Afr J Bioethics Law 2017;10(2):52-54. DOI:10.7196/SAJBL.2017.v10i2.627

The International Covenant on Economic, Social and Cultural Rights (ICESCR) affirms that all human beings are entitled to core rights essential to human fulfilment, such as the rights to work, social security, family life, education and participation in cultural life.[1] Although all human rights and entitlements are important, the ICESCR’s guarantee of ‘the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’ may be the most significant.[1] Individuals and communities at large assign health a special meaning. Having good health is necessary for human wellbeing, as it provides inherent value for comfort, fulfilment and the pursuit of the joys of life. However, good health goes beyond that.[1] Of paramount importance to good health is the freedom of individuals to exercise a wide scope of human rights – civil and political (e.g. personal security and political participation), and social and economic (e.g. education, social security and family life). Health is therefore necessary for wellbeing. When individuals do not have a decent level of health, it is very difficult to achieve the fulfilment of their human rights.[1] People with mental illnesses often find it especially difficult to achieve this, as they face a number of barriers to healthcare, such as inadequate care and treatment, and severe discrimination.[2,3] In many cases, these barriers are motivated by the misconceptions associated with mental illness, and this can impact an individual’s ability to exercise his or her human rights.[2,4,5] Therefore, protecting the human rights of mentally ill people can ensure them their core rights essential to human fulfilment.[1,6] This article discusses human-rights legal instruments, and focuses on the rights to health, life and dignity with regard to the Life Esidimeni (LE) tragedy. It takes into consideration existing challenges to the realisation of the rights of the mentally ill, and examines how the true ‘progressive’ realisation of human rights can have meaningful results for mentally ill people.

International, regional and national human-rights law instruments International and regional human-rights instruments are significant in the context of mental health, as ‘they are the only source of law that legitimises international scrutiny of mental-health policies and practices within a sovereign country, and also because they provide fundamental protections that cannot be taken away by the ordinary political process.’[7] Among these legal instruments is the International Bill of Rights, which consists of the United Nations (UN) Declaration of Human Rights (UDHR, 1948),[8] the ICESCR (1966)[9] and the International Covenant on Civil and Political Rights (1966).[10] Although the UDHR is not, per se, a legally binding instrument, it does establish a fundamental set of human rights that applies to all nations. Other instruments include the Convention on the Rights of Persons with Disabilities (CRPD, 2006),[11] the Convention Against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment (1983)[12] and the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW, 1979).[13] Regional human-rights law instruments include the African Charter on Human and People’s Rights (1986).[14] Nationally, the Republic of South Africa (SA) has its own set of human-rights laws around the rights of mentally ill persons, which are derived from international and regional law.[15,16] SA, having signed and/or ratified the abovementioned international and regional legal instruments, ‘[is] obliged to respect, protect and fulfil the rights enshrined in them’.[7,17] The Bill of Rights, under section 39(1)(b) of the Constitution of SA,[17] states that the courts and other legal bodies ‘must consider international law’, and section 231(2) and (4) state that international law, approved by Parliament, binds the republic to that law. SA is therefore legally and morally bound to respect international and regional legal instruments. Pertinent to the human rights of mentally ill people in SA is the Constitution,[17] the National Health Act No. 61 of 2003 (NHA)[18] and the Mental Healthcare Act No.17 of 2002 (MHCA).[19] The National

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REVIEW Mental Health Policy Framework and Strategic Plan 2013 - 2020 (MH policy)[20] and the White Paper on the Rights of Persons with Disabilities[21] are also important to the human rights of mentally ill people in SA.

The right to health Health is an indispensable human right, needed for the realisation of other human rights, such as life and dignity, and therefore every person ‘is entitled to the enjoyment of the highest attainable standard of health conducive to living a life in dignity’.[9] The ICESCR provides the most comprehensive article on the right to health. In line with article 12.1 of the ICESCR, states recognise ‘the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’.[9] The right to health is also recognised, inter alia, in article 5(iv) of the International Convention on the Elimination of All Forms of Racial Discrimination,[22] and in article 14(b) of the CEDAW.[13] Regionally, the right to health is recognised in the African Charter (article 16).[14] Nationally, the right to health is enshrined in Section 27 of the Bill of Rights: the right to ‘healthcare, food, water and social security.’ The right to health must be progressively realised by the SA state, within its available resources.[17] The Committee on Economic, Social and Cultural Rights of the ICESCR[23,24] gives a detailed account of ‘interrelated and essential elements’ regarding what the right to health entails, and these can help improve a country’s health system. These are availability, accessibility, acceptability and quality. Availability refers to a functioning health system. This includes the underlying determinants of health, such as safe drinking water and adequate sanitation facilities, trained medical personnel and essential drugs,[23] as defined by the World Health Organization (WHO)’s Action Programme on Essential Drugs.[25] The programme classifies drugs for the mentally ill as essential. Furthermore, principle 10 of the United Nations’ Principles for the Protection of Persons with Mental Illness and the Improvement of Mental Healthcare (MI principles)[26] affirms that ‘medication shall meet the best health needs of the patient’. Principle 14(1)(d) states that patients should have access to ‘adequate, regular and comprehensive treatment, including supplies of medication’. An investigation into the LE tragedy conducted by the health ombudsman of SA[27] revealed that patients died of severe dehydration, and that they did not have access to adequate drinking water and sanitation facilities. In addition, the personnel at the non-governmental organisations (NGOs) that they were placed in were not trained medical personnel. Also, many of the patients did not receive their medication – most patients were discharged from Life Esidimeni without their discharge summaries.[27] The failure to discharge patients with their summaries may be because patients were hurriedly removed from the facilities of LE. These actions by the Gauteng Department of Health (GDoH) led to some patients becoming wasted and some dying prematurely.[27] The lack of availability of a functioning healthcare system and access to essential drugs unambiguously violated these patients’ right to health. Accessibility refers to healthcare facilities, goods and services that are accessible to everyone without discrimination on any grounds. The Office of the United Nations High Commissioner for Human Rights states that ‘non-discrimination is a key principle in human rights and it is crucial to the enjoyment of the right to the highest

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attainable standard of health’.[28] However, in the context of the LE tragedy, this was clearly not the case. It was discovered that the ‘plan’ to reduce the number of patients housed at LE by 20% was carried out in an inconsistent manner and to cut costs.[27] The ombudsman’s investigation found it suspicious that NGOs were expected to take care of mentally ill patients at the cost of ZAR112 per day, as compared with the ZAR320 per day that LE charged.[27] Could it be that these patients were discriminated against because they had a mental illness? The investigation found that the cost reduction rationale represented serious forms of neglect and denial (discrimination) of care to the patients.[27] The GDoH is deployed by the state, and therefore a violation of Section 9(3) of the Constitution occurred: ‘the state may not unfairly discriminate directly or indirectly against anyone on one or more grounds, including … disability.’[17] Article 25 of the CRPD states that ‘persons with disabilities have the right to the enjoyment of the highest attainable standard of health without discrimination on the basis of disability.’[11] Acceptability refers to healthcare facilities and services that are respectful of medical ethics, and that improve the health status of patients.[23] There was a total disregard of the values of medical ethics. The patients’ removal from the LE facilities to ill-resourced NGOs resulted in morbidity and mortality, instead of an improvement in health status. The GDoH took no steps to ensure the acceptability of the NGOs. In terms of good quality of healthcare, principle 1(1) of the MI principles affirms that ‘all persons have the right to the best available mental healthcare,’[26] while article 25(a) of the CRPD affirms that persons with mental illness should be provided with quality mental healthcare.[11] Additionally, section 66(b) of the MHCA[19] states that quality treatment must be provided for mentally ill persons. The Act unfortunately does not define what this quality treatment entails. The investigation, however, did find that patients received ‘substandard care’. The investigation also found that several NGOs were in fact residential properties (not healthcare facilities) and did not have suitable infrastructure to house these patients.[27] The NHA defines a health facility as ‘a building or place … designed to provide inpatient or outpatient treatment’,[18] while the MHCA uses this same definition. Therefore, the housing of patients at these residential NGOs was in direct violation of both Acts. In addition, section 24(b) of the Constitution states that ‘everyone has the right to an environment that is not harmful to their health or wellbeing.’[17] The ombudsman’s investigation found that on inspection of the NGOs, the environment was not conducive to patients’ mental health. Many of the NGOs did not have adequate security arrangements, which put patients at an increased risk of danger.[27] Also, many of the NGOs lacked the capacity, skills and competence to look after mentally ill patients, which was in direct violation of section 6(1)(a) of the MHCA,[19] which affirms that mental healthcare must be provided at health establishments within its scope of practice. NGOs provided care outside of this definition.

The right to dignity The notion of dignity is often interlinked with that of social justice. Social justice is generally equated with the notion of fairness in society, including for the most vulnerable. The dignity of each human being in society can only be achieved when every member of society is treated as equal.[2,6]

REVIEW Article 1 of the UDHR,[8] article 3 of the CRPD,[11] article 5 of the African Charter[14] and section 10 of the Constitution[17] affirm that everyone has a right to dignity. The African Charter explicitly states that ‘every individual shall have the right to the respect of the dignity inherent in a human being, and to the recognition of his legal status. All forms of exploitation and degradation of man, particularly … cruel, inhuman or degrading punishment and treatment shall be prohibited.’[14] Regrettably, some of the patients were forced to sleep on floors, went hungry and suffered from dehydration, depriving them of their dignity[27] and subjecting them to cruel, inhumane and degrading treatment, which was also in violation of the Convention against Torture.[12] Once more, the transfer of mentally ill patients is regulated by section 72 of the MHCA.[19] This means that patients should be transferred in a suitable and dignified manner. However, the investigation found that this was not the case. The CRPD[11] highlights dignity of persons with mental disabilities in several articles. Article 19 underpins the right of people with mental disabilities to live in society, equal to others. This aims to ensure the development and growth of people with mental disabilities to achieve self-worth and dignity. Additionally, the care of people with mental disabilities is highlighted in article 25, which requires ‘health professionals to provide care of the same quality to persons with disabilities as to others … raising awareness of the human rights, dignity, autonomy and needs of persons with disabilities through training and the promulgation of ethical standards’.[11] The GDoH, however, by unashamedly failing to adhere to ethical norms and standards, abominably violated the right to dignity of these patients.

The right to life Article 3 of the UDHR,[8] article 10 of the ICESCR,[9] article 10 of the CRPD,[11] article 4 of the African Charter[14] and section 11 of the Constitution[17] affirm that every human being has a right to life. Despite this, the ombudsman’s investigation concluded that patients died under unlawful circumstances, and that their right to life was violated.[27] While the right to health is dependent on the realisation of other rights, a compelling argument can be made for the right to life being dependent on the rights to health and dignity. To illustrate this, article 10 of the CRPD,[11] on which SA based its White Paper, establishes that ‘state parties reaffirm that every human being has the inherent right to life and shall take all necessary measures to ensure its effective enjoyment by persons with disabilities on an equal basis with others.’ The key notion in this affirmation is ‘shall take all necessary measures’, and that includes the realisation of the rights to health and dignity. The GDoH did not take all the necessary measures to fulfil the right to life of these patients. Perhaps, if it had done so, their unlawful deaths could have been averted.

The legal and moral duties of the GDoH SA and its duly appointed subsidiary, the GDoH, are bound by international and regional law under the Constitution (s 231(2) and (4)). The GDoH is required by law to follow and apply any international and regional law relevant to SA. According to section 3(2) of the NHA,[18] ‘every provincial department … must establish such health services as are required in terms of this act, and all health establishments and healthcare providers in the public sector must equitably provide health services.’ In addition, section 25(1) of the act states that ‘the relevant member of the executive council must ensure

the implementation of national health policy, norms and standards in his or her province,’ i.e., in this case, the MH policy. The GDoH and the former member of the executive council (MEC) had a legal and moral duty to ensure that international, regional and national laws, polices and guidelines were being adhered to. Although the NGOs played a huge role in the deaths and ill treatment of these patients, they were contracted by the GDoH, who were fully aware that the NGOs were not capable of caring for mentally ill patients, professionally, medically or structurally. The GDoH was also advised by various stakeholders not to transfer the patients.[27] Therefore, if the department could not provide the requisite standard of care for their patients, they had a legal duty to contract suitably qualified healthcare providers, as stipulated in the NHA.[18] Furthermore, the MHCA,[19] in its preamble, recognises that ‘there is a need to promote the provision of mental healthcare services in a manner which promotes the maximum mental wellbeing of users of mental healthcare services and communities in which they reside.’ Therefore, considering all laws, policies and guidelines cited herein, it can reasonably be concluded that the GDoH fell foul of their legal and moral obligations and duties, by negligently consigning the care of their patients to the hands of incompetent people and/or facilities that lacked the necessary capacity.

Conclusion SA has done considerably well by signing international law and enacting legislation aimed at realising the human rights of mentally ill people. While this is laudable, the Life Esidimeni tragedy is, however, an indication of how far SA is from realising the human rights of the mentally ill. Protecting the rights of mentally ill people is important, as they safeguard patients from neglect and abuse. However, the implementation of laws to defend these rights remains an important factor if we are to avoid tragedies like that which occurred in the Life Esidimeni situation. It is high time that our country moved away from protections being just a paper exercise. Our state has a responsibility to be accountable to all its citizens – even those who are mentally ill.

1. Ruger JP. Health and social justice. Lancet 2004;364(9439):1075-1080. https://doi. org/10.1016/S0140-6736(04)17064-5 2. Maiese M. Human Rights Violations. Beyond Intractability. 2003. http://www. beyondintractability.org/essay/human-rights-violations (accessed 1 September 2017). 3. Mfoafo-M’Carthy M, Huls S. Human rights violations and mental illness: Implications for engagement and adherence. SAGE Open 2014;4(1):1-18. https:// doi.org/2158244014526209 4. Corrigan P. How stigma interferes with mental health care. Am Psychol 2004;59(7):614-625. https://doi.org/625:10.1037/0003-066X.59.7.614 5. Sorsdahl KR, Stein DJ. Knowledge of and stigma associated with mental disorders in a South African community sample. J Nerv Ment Dis 2010;198(10):742-747. https://doi.org/10.1097/NMD.0b013e3181f4b2d7 6. Ebert R, Oduor RM. The concept of human dignity in German and Kenyan constitutional law. Thought Prac 2012;4(1):43-73. 7. Ventura CA. International Law, Mental Health, and Human Rights. Notre Dame: The Center for Civil & Human Rights, 2014. https://humanrights.nd.edu/ assets/134859/venturamentalhealth.pdf (accessed 1 September 2017). 8. United Nations General Assembly. Universal Declaration of Human Rights. Paris: UN, 1948. 217 A (III). http://www.un.org/en/udhrbook/pdf/udhr_booklet_en_ web.pdf (accessed 17 July 2017). 9. United Nations General Assembly. International Covenant on Economic, Social and Cultural Rights. United Nations, Treaty Series, vol. 993. New York: UN, 1966. http:// www.ohchr.org/EN/ProfessionalInterest/Pages/CESCR.aspx (accessed 17 July 2017). 10. United Nations General Assembly. International Covenant on Civil and Political Rights. United Nations, Treaty Series, vol. 999, p. 171. New York: UN, 1966. https:// treaties.un.org/doc/publication/unts/volume%20999/volume-999-i-14668english.pdf (accessed 1 September 2017).

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REVIEW 11. United Nations Division for Social Policy and Development. Convention on the Rights of Persons with Disabilities. UN, 2006. https://www.un.org/development/ desa/disabilities/convention-on-the-rights-of-persons-with-disabilities.html (accessed 17 July 2017). 12. United Nations General Assembly. Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, United Nations Treaty Series, vol. 1465, p. 85. New York: UN, 1984. https://treaties.un.org/doc/Publication/UNTS/ Volume%201465/volume-1465-I-24841-English.pdf (accessed 1 September 2017). 13. United Nations General Assembly. Convention on the Elimination of All Forms of Discrimination Against Women. United Nations, Treaty Series, vol. 1249, p. 13. New York: UN, 1979. http://www.un.org/womenwatch/daw/cedaw/text/econvention. htm (accessed 1 September 2017). 14. Organization of African Unity. African Charter on Human and Peoplesâ&#x20AC;&#x2122; Rights (Banjul Charter). 1986. CAB/LEG/67/3 rev. 5, 21 I.L.M. 58. OAU, 1982. http://www. achpr.org/files/instruments/achpr/banjul_charter.pdf (accessed 17 July 2017). 15. Dugard J. International law: A South African Perspective. Kenwyn: Juta and Co., 1994. 16. Reisman WM. Sovereignty and human rights in contemporary international law. Amer J Intl Law 1990;84(4):866-876. 17. South Africa. The Constitution of the Republic of South Africa Act No. 108 of 1996. http://www.gov.za/sites/www.gov.za/files/Act108of1996s.pdf (accessed 17 July 2017). 18. South Africa. 2003. National Health Act No.61 of 2003. http://www.gov.za/sites/ www.gov.za/files/38486_r10367_gon109.pdf (accessed 17 July 2017). 19. South Africa. 2002. Mental Healthcare Act No.17 of 2002. http://www.gov.za/sites/ www.gov.za/files/a17-02.pdf (accessed 17 July 2017). 20. South Africa. National Department of Health. National Mental Health Policy Framework and Strategic Plan 2013 - 2020. https://www.health-e.org.za/wpcontent/uploads/2014/10/National-Mental-Health-Policy-Framework-andStrategic-Plan-2013-2020.pdf (accessed 9 August 2017). 21. South Africa. Department of Social Development White Paper on the Rights of Persons with Disabilities. 2015. http://www.gov.za/sites/www.gov.za/files/39792_ gon230.pdf (accessed 1 September 2017).

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22. United Nations General Assembly. International Convention on the Elimination of All Forms of Racial Discrimination United Nations, Treaty Series, vol. 660, p. 195. UN, 1965. http://www.ohchr.org/Documents/ProfessionalInterest/cerd.pdf (accessed 1 September 2017). 23. United Nations Committee on Economic, Social and Cultural Rights. Twentysecond Session on The Right to the Highest Attainable Standard of Health (General Comment 14). UN, 2000. http://www.minoritycentre.org/sites/default/files/cescr_ gen_comm_14_health.pdf (accessed 1 September 2017). 24. Robertson RE. Measuring state compliance with the obligation to devote the maximum available resources to realizing economic, social, and cultural rights. Hum Rts Q 1994;16(4):693-714. https://doi.org/10.2307/762565 25. World Health Organization. Action Programme on Essential Drugs. Geneva: WHO, 1992. http://apps.who.int/medicinedocs/pdf/s2237e/s2237e.pdf (accessed 1 September 2017). 26. United Nations General Assembly. The Principles for the Protection of Persons with Mental Illness, resolution 46/119 of 17 December 1991. UN, 1991. http://www.who. int/mental_health/policy/en/UN_Resolution_on_protection_of_persons_with_ mental_illness.pdf (accessed 1 September 2017). 27. Makgoba MW. The Life Esidimeni disaster: The Makgoba report. PoliticsWeb, 1Â February 2017. http://www.politicsweb.co.za/documents/the-life-esidimenidisaster-the-makgoba-report (accessed 10 July 2017). 28. United Nations Office of the High Commissioner for Human Rights. Fact Sheet No. 31, The Right to Health 2008 No. 31. Geneva: UNOHCHR, 2008. http://www.ohchr. org/Documents/Publications/Factsheet31.pdf (accessed 17 July 2017).

Accepted 23 November 2017.

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

SHORT REPORT

Deferential vulnerability and patient decision-making C Ellis, MBBS, MRCS, MD, FCFP Department of Family Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa Corresponding author: C Ellis (cristobalellis@gmail.com)

‘Autonomy is a fantasy. Our lives are inherently dependent on others and subject to forces and circumstances well beyond our control.’ (Atul Gawande, Being Mortal) S Afr J Bioethics Law 2017;10(2):56-57. DOI:10.7196/SAJBL.2017.v10i2.609

Deferential vulnerability arises when individuals subordinate themselves or submit to an authority figure when making decisions about their day-to-day lives and existence within their specific environment and relationships. This customary obedience occurs in cultures where certain hierarchical systems exist within the family or community. Vulnerable individuals may include, but are not limited to, women, children, the elderly and sometimes young adults. Deferential vulnerability may occur within a medical relationship when patients defer to the authority of other family members or agencies when making health-related decisions. These decisions may not necessarily be involuntary or even be given unwillingly (that is, they may not necessarily be under direct duress or coercion), but the patient either makes decisions based on advice or directives from authority figures, or defers the decision in its entirety to such figures recognised by his or her cultural, community or religious contexts and customs. This can result in grey areas between acquiescence and voluntariness in the consent process. They often place the medical practitioner in a difficult situation as, on the one hand, the law requires consent from an individual patient or their legal proxy, and on the other hand, obtaining consent in an ethically sound manner requires consent to be a process in which effective decision-making is facilitated. There is one further step that many African and indigenous communities worldwide may take in deferment, and that is to consult the ancestors or forefathers. Every now and then, the relatives of a patient may ask to take the patient home so that sacrifices (usually a goat or a cow) may be made to the ancestors, and also defer to a traditional healer to seek guidance in their consent deliberations. Another form of deferential vulnerability may occur in more conservative traditional families. Female patients from these families are usually accompanied by a male member of the family, such as the husband, brother or father. Decisions are often made by the family as a community, as opposed to a Western individualistic decision that is left to the patient alone. In these particular circumstances, women may be vulnerable, but alternatively, may also be protected, depending on the specific dynamics within the family. A recent case involved a 2-year-old Zulu child who needed a shunt owing to increasing intracranial pressure from a hydrocephalus. The mother was willing to give consent for the operation, but the father was unwilling, and the mother’s mother (the child’s grandmother)

also objected to the operation. In South African law, only one parent needs to give consent for a child’s operation. If there is a dispute, the key criterion is, what is in the best interests of the child? Zulu society is still, to some extent, patriarchal in nature, and the grandmother of a family also holds considerable authority concerning decisions over health matters. In this particular case, the mother, although willing, would not sign the consent forms out of deference to the authority of the father of her child and also the grandmother. This scenario demonstrates the potential impact of deferential vulnerability, as here the child was denied an important procedure because of concerns expressed by authority figures. The influence of the family or community on individual choices is a subtle aspect of decision-making. This may not be as straightforward as it seems, because if I live in a society in which my partner makes all the decisions, and I am in agreement with this arrangement, then according to some ethicists, it is considered autonomous behaviour to let my partner make decisions on my behalf. We know that there are many subconscious influences at play when one consents to a procedure or operation, yet when people in groups are asked to make decisions they may come to very different conclusions than when asked to make such decisions individually. Although we all value information concerning our illnesses, we may not be as enthusiastic about making decisions for ourselves as theorists assume. In some situations we may prefer to let someone else decide for us. This is similar to the Sartrian view that man is condemned to be free, but does not necessarily enjoy the responsibility or burden of this freedom. In obtaining informed consent one of the first steps is to check that the technological information has been relayed and understood by the patients and those assisting them. Even understanding the basic concepts and the words used to describe them is often difficult. The impasse with the child with rising intracranial pressure was solved by involving a traditional healer, along with the hospital counsellor, to explain the situation to the father and grandmother in a way and in a language that they could fully understand. In this way, cumbersome as it may seem, the authority figures in the child’s and mother’s life were brought into the decision-making process, thereby ensuring that the child’s best interests were served. We all surrender part of our decision-making rights in systems with which we are unfamiliar, or to persons with the relevant knowledge

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SHORT REPORT or power, be they lawyers, accountants or electricians. In addition, however well-informed we are, we often have problems subjectively balancing the risks and benefits of any action, especially when it comes to medical treatment. While the ideal would be fully autonomous, uncoerced decisions, no one is fully autonomous â&#x20AC;&#x201C; neither doctors nor patients. Despite these several restrictions and influences, we aspire to obtain the best quality of consent and decision-making for our patients. The question arises as to whether one uses Western ethical and communication

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models, or creates new models which are co-constituted by agreements between Western technological cultures and indigenous or traditional cultures. The best way forward may be to gradually introduce integrative models by increasing our communication skills and patient education, and also beyond the patient, to those in authority in their lives. This is not entirely possible without simultaneous social and educational change in the index populations. Accepted 17 October 2017.

ARTICLE

This open access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Informed consent and deafness in South Africa: Guidelines for clinicians and researchers C Penn, PhD; V de Andrade, MA, PhD Department of Speech Pathology and Audiology, School of Human and Community Development, Faculty of Humanities, University of the Witwatersrand, Johannesburg, South Africa Corresponding author: C Penn (Claire.Penn@wits.ac.za)

Persons with severe to profound hearing loss are potentially vulnerable participants in research trials. Standard enrolment practices are likely to threaten or limit the process of informed consent. Misconceptions held by the hearing community about hearing loss and the impact of amplification of hearing, as well as on the nature of signed language, may jeopardise the process. This is particularly the case in the complex sociopolitical context of South Africa, which has significantly influenced the educational and linguistic status of deaf persons. This paper describes factors of importance, and suggests a number of guidelines for researchers using deaf participants. The paper will highlight some relevant dimensions of deafness to take into account, and the impact of socioeconomic context on this issue. Three case examples will be used to illustrate the complexities of the issues. S Afr J Bioethics Law 2017;10(2):58-61. DOI:10.7196/SAJBL.2017.v10i2.541

There is a significant history of exploitation of and unethical experimentation with deaf people across the centuries – a factor which Harlan Lane[1] and others have described, and which has led to a strong deaf-rights movement and acute concern with ethical practices.[2] In the unique context of South Africa (SA), with its particular illness profile and recognised historical, social and educational inequities, deaf individuals are rendered especially vulnerable.[3] While it might be argued that most researchers working with deaf people will already have an understanding of these factors, it cannot be assumed, especially in biomedical research, that the researchers are familiar with the complexity of argument. Many myths and assumptions continue to exist in the field of deafness. This article addresses some important variables to consider when undertaking research with deaf individuals, provides some case examples to illustrate issues of informed consent and suggests some guidelines to ensure proper informed consent for this vulnerable group.

Factors of relevance

The person who has acquired oral language before becoming deaf, and who had normal hearing during the critical language-learning years of childhood, will retain such oral language skills in the event of severe or profound hearing loss. A typical cause of such profound acquired deafness is this country is meningitis. Another alarming and currently prevalent cause is ototoxicity. Tuberculosis (TB) patients on treatment are at high risk for sudden and profound hearing loss as a consequence of the ototoxic properties of some of the lifesaving drugs they take.[9] While such individuals with acquired hearing loss may no longer be able to hear, reading and writing will be unaffected, and lip-reading skills may assist their understanding of others. Of course, the profound trauma of permanent and sudden hearing loss, and the social isolation that may ensue, will render such individuals further vulnerable. Furthermore, given the current epidemiology of TB, it is likely that some of these individuals will come from communities in which literacy may be limited, because of lack of educational opportunity.

Severity and type of hearing loss

‘Deafness’ v. deafness

Hearing loss is measured on an audiogram, and typically, severe to profound bilateral hearing loss is associated with marked difficulties with the acquisition of spoken (or oral) language. Despite huge advances in technology, including high-powered hearing aids and cochlear implantation, children with a congenital severe to profound hearing loss may have minimum benefit from amplification, and will require specialised and regular input and education to acquire oral language skills and literacy. The success of such amplification and rehabilitation attempts will depend on the age at diagnosis and access to suitable rehabilitation. In SA, limited resources, awareness and access, and inadequate follow-up, account for delayed diagnosis and intervention.[4-8] Age at acquisition of hearing loss makes a substantial difference.

A distinction is widely recognised between ‘Deafness’ as a cultural category and deafness as a biomedical category. The use of the lowercase ‘deaf’ refers to people who may have audiological deafness as described by their audiometric results and their measurable deafness. They tend to use hearing aids to support their use of spoken language.[10] The upper-case ‘Deaf’ refers to the cultural and social categorisation of people who identify with Deaf culture. Deaf (in the upper-case sense) people do not consider themselves disabled; instead, they consider themselves part of a minority grouping whose members share similar beliefs and a ‘naturally occurring human identity … manifest through … norms of behaviours, cultural perspective, conventions and shared histories’.[10] The identity of being Deaf, and the experience of being deaf and Deaf, seems

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ARTICLE to transcend other identities, such as ethnicity, because ‘common experiences seem to have shaped their Deaf identity, in the sense that alienation from hearing people has led to solidarity among Deaf people (even from different ethnicities).’[11] The implications of this distinction are important for a researcher using deaf participants. We can assume neither deafness nor Deafness, until we ask. The presence of a hearing aid and the use of sign language provide some clues, but individuals often consider themselves to be both, depending on the people they are communicating with. These identities will have a significant impact on the process of informed consent.

Education and literacy

recognition of the country’s eleven official languages, it also makes provision for the Pan South African Language Board to promote and develop SASL.[16] SASL has also recently been recognised as an additional language for teaching at schools.[17] Despite such enabling legislation based on the Constitution, SASL remains, by and large, a stigmatised language variety in the SA context, and there remain many misconceptions about it even amongst linguists, health professionals, educators and policy makers. Another important factor in understanding challenges to informed consent is the fact that there are regional and dialectal variations in sign language. Deaf people in SA continue to use a number of sign dialects. Because of a history of segregated education systems, a wide variety of sign-language dialects exists, determined not only by region and ethnicity but by the educational background of the Deaf individual,[18,19] which often do not match the dialectal version of the interpreter appointed by the researcher.

Research evidence suggests that internationally, the literacy level of deaf school-leavers is about Grade 5. Many reasons for this exist, including the fact that there is often a mismatch between the needs of the child and the educational programmes offered.[12,13] Although plain and simple language is the hallmark of all good written informed consent, those compiling a written informed-consent sheet for deaf persons should be aware of the difficulties with literacy faced by most deaf persons, and the possible interference of another language (sign language) on the understanding of grammatical devices such as word order or the passive construction. It is acknowledged that signed language is ‘not grammatically structured in a linear subject-verb-object structure. Rather it is a topic-comment language in which inflection is produced through facial expression, visual orientation, movement and spatial location.’[14] The researcher should therefore be careful not to assume full understanding of written text without carefully checking. To this end, it is also advisable to prepare consent forms that have been submitted to a readability analysis to check the reading age and grade level at which the consent forms have been written. This is obviously compounded by the fact that in SA, the language of schooling is usually different from the oral language of the home. All specialised schooling for the deaf in SA takes place in English and Afrikaans, and the mismatch between home and school language exposure poses another obstacle to age-appropriate language development. The multilingualism policy has created a complex and typically SA situation where, in the context of 11 official languages, deaf people who speech-read are expected to do so in various spoken languages.[7,15]

Several threats to anonymity and confidentiality exist when working with deaf individuals in research (and indeed in any clinical interactions between deaf persons and healthcare professionals). The first of these links to the role of video-recording. The advent of the videotape has enabled a full appreciation and documentation of the complexities of sign language. Because sign language is temporally fleeting, video-recording is often the only reliable way to collect and store data from Deaf people and to check the reliability of the process of informed consent. This presents additional challenges in the process of gaining informed consent, as currently in the hearing world, significant limitations are placed on research using video-taping with human participants because of issues of confidentiality.[20] The way that the data are presented in publications is also an important issue. Janse van Vuuren[21] has suggested that ‘researchers in sign language are faced with a challenge which is unavoidable in the context of a visual-gestural language: participants are always identifiable because non-manual features (including facial expressions) form an important part of the linguistic structure of the language. Often, still-frames of digitally recorded signed texts are used in research publications to show these features. The implication of this is that participants have the right to know exactly how the digital texts will be utilised.’

Sign language

Interpreting quality and confidentiality

Sign language is the natural language of the deaf community, and like spoken language, is complex, grammatical and nuanced. Specifically for Deaf people, the use of sign language is a hallmark of their identification with Deaf culture and ethnicity, and for significant numbers of Deaf people, it functions as their primary vernacular language, while people who are deaf may use hearing amplification devices and spoken language or spoken and signed language. There is a natural sign language in SA, South African Sign Language (SASL), that is used by the Deaf in communicative interactions and that is characterised by extensive lexical variation, related to regional and educational background, but underlying syntactic unity. Although it is not an official language in SA, there have been calls to recognise SASL as an official language, and, in the Constitution’s

The use of a sign-language interpreter is strongly recommended when recruiting Deaf persons in research studies, especially if sign language is used as his/her main medium of communication with family and peers. At present, because of discrepancies between policy and practice, fewer than 100 SASL interpreters are officially registered in SA.[22] This poor provision and regulation of interpreting services results in inadequate services. Nowhere was this more vividly demonstrated than in the fake sign-language interpreter debacle of Nelson Mandela’s funeral.[23] Another challenge exists around issues of confidentiality when working with the Deaf community, when a sign-language interpreter is used in an informed-consent process. Typically, the Deaf community is a small community with defined familial, professional and social

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Anonymity and confidentiality considerations

ARTICLE Table 1. Three research studies using Deaf and deaf participants illustrating the management of informed-consent issues Case study 1) De Andrade[25]

Goal of study To explore the experiences of caregivers of deaf children in a rural context

Participants Deaf parents of Deaf children were interviewed

Adaptations for deafness Two third parties used to gain informed consent: a Deaf teacherassistant with a longstanding history of engagement with the Deaf community in this district, and a hearing person with a number of deaf and Deaf family members, fluent in the regional SASL dialect

Data management The data (including the process of informed consent) were videorecorded and later transcribed by a Deaf sign language user who is a lecturer in SASL

2) Penn, et al.[24]

To describe the linguistic and cognitive profiles of five deaf adults with a sign-language disorder

Two clinical groups were studied: three male learning‐disabled deaf adult signers and two male deaf adult signers with acquired right-hemisphere damage as a result of a stroke; their performance was compared with that of five male deaf controls matched for age, degree of deafness and signing dialect

The test battery was translated into two sign dialects in SA and included only one-handed signs (to control for the presence of hemiplegia). All test instructions were given in sign language. All the tests were piloted on three deaf persons prior to the study. A carefully selected and trained signlanguage interpreter was involved at each of the research sites

The process of informed consent and all participants’ responses on the test battery were video-recorded and later scored and analysed by two adult deaf signers and the researchers, with high levels of inter-rater agreement

3) Janse van Vuuren[23]

To document classifiers in sign language narratives

Five deaf adult signers in Johannesburg, SA

Each participant received the written participant-information sheet and informed-consent form. The researcher (fluent in sign language) also translated these documents into SASL, which was recorded on DVD and given to each participant to take home and view before giving consent

As the data presented in the thesis (and in future publications) are linked very specifically to still photo frames, the researcher made explicit all possible uses of the visual data in the letter of consent

SA = South Africa; SASL = South African Sign Language.

networks.[10] This implies the need to explain and reinforces the need to protect the participants’ rights to anonymity and confidentiality. In the absence of a formally trained interpreter, while it might be possible to deploy persons in the participant’s environment such as family members, there are ethical problems with this choice, such as the risk of coercion, and this suggests the need for some checking of the integrity of the process. As with any third party in research-project selection, proper briefing and monitoring of the interpreter are important. The person selected should be regionally, educationally and dialectally matched to participants to ensure an efficient process. Furthermore, where a sign-language interpreter is deployed, it will be difficult for the hearing researchers to monitor the effectiveness and accuracy of the process (as indeed it is for hearing persons in an interpreter-mediated oral-language informed-consent session in a multilingual context). This implies the need for some checks and balances around the validity of the procedure (see for example case study 2 in Table 1). Because of the visual nature of sign language, ethically, the venues chosen for conducting the interviews need careful consideration to ensure confidentiality. Similarly, good lighting is required in the data-collection setting to ensure proper access to signs and facial expressions for research participants.

Distress-protocol considerations Because of the broader vulnerabilities of deaf and Deaf persons in our society to illness, including HIV/AIDs, sexual exploitation and mental-health issues, it should be borne in mind that aside from language difficulties, the specific research topic may pose some additional challenges for deaf people, and may require the use of a specific distress protocol. Clearly, referrals and actions should be commensurate with the participants’ communication preferences and abilities, and should incorporate professionals such as social workers, counsellors and psychologists who are familiar with deafness.

Illustrative case studies In Table 1, three studies using deaf participants are summarised that reflect adaptations from standard research protocol to the process of informed consent. These studies illustrate: the use of a combination of written and signed instructions; a sensitivity to regional variations of sign language; the use of videotape in research; and sensitivity to confidentiality issues.

Recommendations Based on these considerations, a summary recommendation sheet for the use of RECs is proposed below.

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ARTICLE Informed consent and the Deaf community: Suggested guidelines Protocols involving the use of deaf persons as participants will need to take into account the following: • the level of deafness of the individual • whether the hearing loss is congenital or acquired • the level of education and literacy of the proposed participant. Certain members of the Deaf culture may be considered potentially vulnerable in the research setting. For severely to profoundly deaf individuals, oral language skills (talking and lip reading) and literacy may be a problem. This is particularly the case for congenital deafness, as literacy for persons with acquired deafness (after school age) is likely to be inadequate. The presence of a hearing aid (or cochlear implant) does not imply that the message is adequately heard! It is possible therefore that a standard informed-consent approach is inappropriate, and researchers should bear in mind the following factors.

The written form Research evidence suggests that internationally, the literacy level of deaf school leavers is about Grade 5. Special efforts should therefore be made to make the written version of the form user-friendly – simple language (vocabulary and sentence length), clarification of terms, etc. Pictorial supplements may help here. Note that given current special-education policy in SA, English (or Afrikaans) is likely to be the language of education and literacy, regardless of the spoken oral language of the person’s background.

The verbal/sign form The use of a sign-language interpreter is strongly recommended, especially if the deaf person concerned is a member of the Deaf community and uses sign language as his/her main medium of communication with family and peers. Sign language (like spoken language) has many varieties, and the researcher should endeavour to ensure that the interpreter deployed is familiar with the dialectal variety of the participant. Videotaping is frequently a necessary aspect of research with the deaf, and should be viewed from a different perspective from the use of video with hearing persons. Extra precautions should be taken to ensure confidentiality. Adequate lighting is essential for sign language, and privacy is essential (because of the strong visual nature of the message). Special care should be taken to inform the participants of how and where the material will be published (particularly in the case of photographs or videotaping). There are sign-language interpreters available through organisations such as the Deaf Federation of SA. It might also be possible to deploy persons in the participant’s environment, such as family members. However, there are ethical precautions with this choice (e.g. the possibility of coercion) that may operate here, and ideally there should be some checking of the integrity of the process. We would recommend that both written and signed versions of the informed-consent process are made available, and that researchers are advised to specify the particular steps taken to minimise vulnerability and reduce distress in the informed-consent process in their ethics applications.

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Conclusion This paper has highlighted the special vulnerabilities of deaf persons taking part in clinical trials, the complexities around the use of the term ‘deafness’ and some particular considerations which need to be taken into account by research ethics committees when reviewing protocols for studies involving deaf and Deaf persons. The recommendations will hopefully serve as a practical guideline which can obviously be supplemented by the appointment of consultants where relevant from the Deaf community. Ethical informed consent with deaf/Deaf particpants will require explicit insight into potential barriers to enrolment and the deployment of context-specific strategies and resources. 1. Lane H. When the Mind Hears: A History of the Deaf. New York: Random House, 1989. 2. NIH Guidelines on Communicating Informed Consent for Individuals who are Deaf or Hard-of-Hearing and Scientists. Bethesda: National Institutes of Health, 2016. https://www.nih.gov/health-information/nih-clinical-research-trials-you/g (accessed 11 August 2017). 3. Reagan T, Penn C, Ogilvy D. From policy to practice: Sign language studies in postapartheid South Africa. Lang Policy 2006;5(2):187-208. https://doi.org/10.1007/ s10993-006-9002-y 4. Swanepoel D, Störbeck C, Friedland P. Early hearing detection and intervention in South Africa. Int J Paed Otolaryngol 2009;73(6):783-786. https://doi. org/10.1016/j.ijporl.2009.01.007 5. Parkin I. Factors affecting deaf education in South Africa. Am Ann Deaf 2010;155(4):490-493. https://doi.org/10.1353/aad.2010.0038 6. Penn C, Reagan T. How do you sign ‘Apartheid’? The politics of South African sign language. Lang Plan Lang Behav 1990;14(2):91-103. https://doi.org/10.1075/ lplp.14.2.02pen 7. Penn C. Signs of the times: Deaf language and culture in South Africa. S A J Comm Dis 1993;40:11-24. 8. Kerr G, Tuomi S, Müller A. Costs involved in using a cochlear implant in South Africa. S Afr J Comm Dis 2012;59(1):16-26. https://doi.org/10.7196/SAJCD.117 9. Petersen L, Rogers C. Aminoglycoside-induced hearing deficits – a review of cochlear ototoxicity. S A Fam Prac 2015;57(2):77-82. https://doi.org/10.1080/20 786190.2014.100222 10. Young A, Hunt R. Research with d/Deaf People. London: NIHR [National Institute for Health Research] School for Social Care Research, London School of Economics and Political Science, 2011. 11. Van Herreweghe M, Vermeerbergen M. Deaf perspectives on communicative practices in South Africa: Institutional language policies in educational settings. Text Talk 2010;30(2):125-144. https://doi.org/10.1515/TEXT.2010.007 12. Kennedy CR, McCann DC, Campbell MJ, et al. Language ability after early detection of permanent childhood hearing impairment. New Engl J Med 2006;354(20):2131-2141. https://doi.org/10.1056/nejmoa054915 13. Moses AM, Goulos DB, Roemen B, Cregan GE. The current state of early literacy for deaf and hearing children: A survey of early childhood educators. J Early Child Literacy 2016;16:1-23. https://doi.org/10.1177/1468798416671173 14. Temple B, Young A. Qualitative research and translation dilemmas. Qual Res 2004;4(2):161-178. https://doi.org/10.1177/1468794104044430 15. Magongwa L. Deaf education in South Africa. Am Ann Deaf 2010;155(4):493-496. https://doi.org/10.1353/aad.2010.0042 16. Constitution of the Republic of South Africa. Act No. 108 of 1996. 17. Department of Basic Education. Education for All (EFA) 2013 country progress report: South Africa. Pretoria: Department of Basic Education, 2013. 18. Reagan T, Penn C. Language policy, South Africa and the deaf: Social and educational implications. S A J Appl Lang Stud 1997;5(1):1-13. https://doi.org/10. 1080/10189203.1997.9724654 19. Penn C, Reagan T. The properties of South African Sign Language: Lexical diversity and syntactic unity. Sign Lang Stud 1994;84:319-327. https://doi.org/10.1353/ sls.1994.0011 20. Mackay WE. Ethics Lies and Videotape. CHI Proceedings, 1995. http://www.sigchi. org/chi95/proceedings/papers/wem1bdy.html. 21. Janse van Vuuren N. An Exploratory Description of Classifiers in South African Sign Language. MA thesis. Johannesburg: University of the Witwatersrand, 2017. 22. DeafSA. Policy on the provision and regulation of South African Sign Language interpreters. Westhoven: Deaf Federation of South Africa, 2011. 23. Pienaar MA, Cornelius E. Contemporary perceptions of interpreting in SA. Nordic J Afr Stud 2015;24(2):186-206. 24. Penn C, Ogilvy D, Commerford A. Spatial and facial processing in the signed discourse of deaf signers with right hemisphere damage and language impairment. Clin Ling Phon 2007;21(5):369-391. 25. De Andrade V. ‘We do not understand each other’: The experience of caregivers of deaf children in a rural South African setting. PhD thesis. Johannesburg: University of the Witwatersrand, 2015. Accepted 23 October 2017.

ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Password compliance for PACS work stations: Implications for emergency-driven medical environments T B Mahlaola, M Tech (Radiography); B van Dyk, M Tech (Radiography) Department of Medical Imaging and Radiation Sciences, Faculty of Health Sciences, University of Johannesburg, South Africa

Background. The effectiveness of password usage in data security remains an area of high scrutiny. Literature findings do not inspire confidence in the use of passwords. Human factors such as the acceptance of and compliance with minimum standards of data security are considered significant determinants of effective data-security practices. However, human and technical factors alone do not provide solutions if they exclude the context in which the technology is applied. Objectives. To reflect on the outcome of a dissertation which argues that the minimum standards of effective password use prescribed by the information security sector are not suitable to the emergency-driven medical environment, and that their application as required by law raises new and unforeseen ethical dilemmas. Method. A close-ended questionnaire, the Picture Archiving and Communication System Confidentiality Scale (PAC-CS) was used to collect quantitative data from 115 health professionals employed in both a private radiology and a hospital setting. The PACS-CS sought to explore the extent of compliance with accepted minimum standards of effective password usage. Results. The percentage compliance with minimum standards was calculated. A significant statistical difference (p<0.05) between the expected and observed data-security practices was recorded. Conclusion. The study interrogates the suitability of adherence to minimum standards of effective password usage in an emergency-driven medical environment and calls for much-needed debate in this area. S Afr J Bioethics Law 2017;10(2):62-66. DOI:10.7196/SAJBL.2017.v10i2.600

The effectiveness of password usage in data security has been heavily criticised. A variety of assumptions regarding password usage have been made, depending on the focus of the literature. From a technical perspective, passwords are considered ineffective in restricting access only to individuals with authorised and legitimate access to data.[1] Engineers suspect that human factors play a significant role in determining the effectiveness of technical safeguards, so that human beings are deemed the weakest link in data security.[2] It remains unclear whether the use of passwords is effective in safeguarding electronic data. Literature findings do not inspire confidence in the usage of passwords for data security. Several quotes taken from various points in time attest to this fact, for example: ‘Boot passwords, put your computer under lock and key’;[3] ‘Goodbye passwords, you aren’t a good defense’[4] and more recently, ‘Forget passwords – use your face instead’.[5] There is extensive literature focusing on the effectiveness and suitability of password usage in preventing confidentiality breaches within environments such as computer security. The researchers have no knowledge of similar studies relating to the suitability of password usage within the medical environment. The aim of this article is to bring to the fore factors unique to the medical environment that argue against the direct ‘copy and paste’ adoption of the minimum standards for effective password usage from computer security into the medical environment.

Background The use of passwords is ineffective in restricting access only to individuals who are authorised to access data. This popular and easy

means of controlling access to data may, in fact, provide the easiest way to breach confidentiality. Information technologists insist that with proper management, passwords are an effective means of protecting the security of data. Measures include, but are not limited to, the use of strong passwords, having individual rather than shared passwords and changing passwords on a regular basis.[6] Compliance with the minimum standards for effective password usage requires knowledge of and to some extent expertise in data security on the part of the healthcare provider.[7] However, the responsibility to comply cannot be placed solely on the healthcare provider. Standards for effective password usage should be well accepted and applied by all users of the technology. At times, factors unique to the medical field may influence the acceptance of security measures. For instance, in a medical emergency, there may be a legitimate need to circumvent the minimum standards of effective password usage in order to save a life.[2,8] It is for this reason that the contributions of both human and technical factors in normative research are noteworthy, but will never be adequate if the context in which technology is applied remains excluded. This paper draws on the assumption that the situated use of technology creates challenges to the inscribed ethics of technology use, resulting in the emergence of new ethical dilemmas. Based on this assumption, we argue that the proper management of passwords as described in the environment of computer security is not suitable to the emergency-driven medical environment. In this paper, we reflect on the research outcome of the first author’s dissertation in putting this argument forward.[9]

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ARTICLE Methods Picture Archiving and Communication System (PACS; RamSoft, USA) is a digital storage system designed to address the limitations of film and paper records. The conventional storage system imposed disadvantages that became an impediment to the continuity of patient care, because the records could be easily misplaced and therefore difficult to retrieve, resulting in delayed medical treatment.[10] PACS is inherently a radiology archiving system that may be extended to various other sections within a hospital. It allows for remote and instant access to radiology data by a multidisciplinary complement of health professionals (HPs) who are based in different locations within a hospital setting, so that the data of the same patient may be accessed simultaneously by different HPs.[11] PACS has contributed to improved patient care by increasing efficiency and the accessibility of data, and has led to fewer delays in the clinical management of patients.[11] The electronic nature of PACS makes it possible for patients’ data to be accessed, duplicated and exported without the patient’s knowledge and consent.[12] The use of passwords aids in restricting access to PACS data, to minimise the risk of breaching patient confidentiality. The original research aimed to determine the extent to which the practices of HPs complied with patient-confidentiality principles when using PACS. The study invitation was initially extended to six hospitals in Johannesburg. However, owing to a 75% refusal rate among this group, the eventual study sample was drawn instead from a private hospital and radiology setting affiliated to different healthcarefacility groups located in Johannesburg instead. The selection criteria included HPs who were willing to participate and were using PACS as either part of routine activity or as a means of delivering patient care. The study sample comprised a multidisciplinary complement of HP such as radiologists, radiographers, student radiographers, doctors, medical specialists and nurses. Prior to data collection, ethical clearance was obtained from the research settings as well as the research committee of the University of Johannesburg (ref. no. HDC67/02-2011), South Africa (SA). Data were collected from various sections within the hospital, namely radiology, emergency, casualty, theatre, intensive-care units including coronary care, acute care, respiratory, trauma intensive care, neurology and surgical-care units. Data were collected over a period of 3 months using a self-designed questionnaire, the Picture Archiving and Communication Confidentiality Scale (PAC-CS). Consent was obtained verbally, and implied through the completion of the PAC-CS. Informed consent was ensured by allowing participants to ask questions relating to the study, and the data were anonymised. Access to study data was restricted to the researchers. The PAC-CS design was informed by the content of the ISO/IEC 17799:2005)[13] standard, from which the constructs, the choice of questions and the quantification were derived and adapted. The ISO/IEC 17799:2005 is a model used in information technology to benchmark an organisation’s compliance with international standards of data security. The consistency of the PACS-CS design with the ISO 17799 model helped to establish its content validity and reliability. A sample size of 115 participants was achieved through the hand-delivery of PAC-CS using a non-probability quota-sampling technique.[14] A quantitative, correlational design was deemed suitable for determining the extent of compliance of the situated practices of

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effective password usage by HPs with minimum standards for effective password usage. The lack of guidelines pertaining to PACS by the Health Professions Council of SA (HPCSA) at the time of this study led to the use of the Health Insurance Portability and Accountability (HIPAA)’s security rule of 1996 as an alternative model for compliance with data-security rules.[15,16] The HIPAA security rule is a detailed outline of the national standards and steps necessary to protect electronic health information from inadvertent disclosures through breaches of security. The choice of this US legislation was informed by its reputation as one of the best regulatory rules pertaining to electronic data security, embedded in the fact that it is continually updated in line with technological advances, and most importantly, addresses the security needs of PACS technology explicitly.[16] The participant responses were analysed by an independent statistician using the Statistical Package for Social Sciences (SPSS, USA) version 16. The quantified responses were expressed in terms of frequency counts and compliance percentage. A 90% benchmark was set for minimum compliance with technical safeguards, whereas a 10% benchmark indicated an intolerable level of non-compliance. Statistical significance (p>0.05) was calculated using the one-sample c2 test for non-parametric data, the choice of which was informed by the lack of randomisation, the sample size and the type of data collected.[14] While the cross-tabulations were used to determine the degree of statistical significance, the phi coefficient helped to calculate the extent of the correlation, the strength of which was determined by the Pearson c2 test. Section A of the PAC-CS focused on the compliance of technical and physical safeguards with international standards. The responses to the close-ended questions regarding technical safeguards in terms of password usage, namely the type of passwords and the frequency of password changes, will be presented.

Results The study results were evaluated in line with the following definition: the situated practices for effective password usage of HP are conceptually defined as the complete range of functions, activities, roles, responsibilities and decision-making capabilities in which individuals are competent, educated and authorised to perform within a specified work environment in complying with the minimum standards of effective password usage. In Table 1 and Fig. 1, the study questions and the corresponding responses that relate to the effectiveness of passwords when using PACS technology are summarised. According to Table 1, 102 participants (90% of the sample) were expected (EN) to use individual passwords to access PACS. Only 27% of the participants complied with the use of individual passwords, while the remainder, 78%, used shared departmental codes instead. A further 23% of participants accessed PACS without requiring a password, and only 2% changed their PACS passwords on a monthly basis. Moreover, a mere 3% of the PACS workstations remained active for less than a minute. In determining the extent of the non-usage of passwords, cross-tabulations between the radiology and nonradiology groups were conducted. Fig. 1 demonstrates that staff members in radiology departments accessed the PACS workstations without the use of an access code to a greater extent than their nonradiology counterparts.

ARTICLE Table 1. Summary of effective password usage Benchmark Response Expected, n (%) Do you have a unique PACS access code? (N=113) Yes=90% Yes 102 (90%) No 11 (10%) Does your department have a PACS access code which everybody uses? (N=114) No=90% Yes 11 (10%) No 103 (90%) Can you access data from the PACS without using an access code? (N=110) No=90% Yes 11 (10%) No 99 (90%) Approximately how long does the PACS work station remain active? (N=113) <1 min <1 min 102 (90%) 90% 1 min 8 (7%) >1 min 2 (2%) All the time 1 (1%)

Observed, n (%)

Extent of compliance*

31 (27%) 82 (73%)

27%

89 (78%) 25 (22%)

22%

25 (23%) 85 (77%)

77%

3 (3%) 4 (4%) 44 (39%) 62 (54%)

*p=0.000

60 Can you access data from PACS without using an access code/ password?

Responses, %

50 40

Yes No

30 20 10 0 Non-radiology

Radiology HP group

Fig. 1. Cross-tabulations on effective password usage between radiology and non-radiology Picture Archiving and Communication System (PACS) users. A significant difference was indicated (p<0.05) between the observed practices and the expected password requirements. (HP = health professional).

Discussion PACS workstations are purposefully designed to provide instant access to data. By design, PACS is inherently a password-driven technology. The password requirement serves: (i) as a means of restricting access to data only to authorised PACS users; and (ii) to authenticate the person accessing the data. The password-driven nature of PACS in itself is a form of an inscribed ethic designed to protect the confidentiality of patient data stored in the PACS. In protecting confidentiality, patientsâ&#x20AC;&#x2122; privacy is secured, and the intrinsic value of patients as human beings is recognised. Not all types of passwords are considered effective in delivering the ethics inscribed in PACS technology. The minimum standards for effective password usage necessitate that passwords are long and contain a variety of characters that would not be easy to crack.[6] As a gold standard, individual passwords rather than shared passwords are recommended, and these need to be changed frequently. The benefit of effective access restriction is the protection of patient confidentiality, which HPs are obligated to uphold. In the original study, the motivations informing the choice of passwords for the

various departments within a hospital setting could not be ascertained. This paper draws on other literature findings to explore possible reasons for poor compliance with the minimum standards of effective passwords, specifically for emergency departments. The study outcomes vary from 27% of participants using individual passwords, to 78% who used shared departmental passwords. In cases where the automatic log-off was disabled, participants accessed PACS without requiring passwords, and this accounted for 23% of the results. The multidisciplinary nature of the study participants introduces a range of functions, activities, roles and responsibilities that should be considered within a specified work environment when explaining the inconsistency in the types of passwords used. It appears that some sections within the hospital setting used passwords that were unique to each department and shared by all members within that particular section, accounting for the 78% use of shared departmental passwords. It could not be ascertained whether the choice of departmental passwords complied with the requirement for hard-to-crack passwords. It may be postulated that the departmental password should be easy to remember, and have predictable features that are not consistent with hard-to-crack passwords. Perhaps the staffing issues unique to the medical setting provide compelling reasons for the use of departmental passwords. For instance, nursing departments employ a significant number of temporary staff, while casualty officers and some specialist doctors, such as traumatologists, work on an on-call basis whereby they may rotate within the public and private sectors. Setting up an individual password for each of the temporary and rotational staff may be a costly, time-consuming and futile exercise when a staff member may be employed only for one day. It may not be possible to set up passwords for an urgent replacement organised at the last minute to replace a staff member who called in sick for duty. Unlike general wards and intensive-care units where nurses, referring doctors and radiographers could all access PACS, the radiology department is mainly accessed by radiology staff, making it susceptible to practices of accessing PACS without requiring a password. This practice may be endorsed by the culture of trust that dominates medical environments, in which HPs are considered to be ethical beings who respect confidentiality and therefore require minimal supervision.[7] Emergency and theatre departments may be

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ARTICLE a further example of environments where passwords are not utilised. In contrast, doctors’ consulting rooms may be suitable for the use of individual passwords, accounting for the 27% reported in this study. The advantage of using individual passwords is that improper conduct relating to data security may be traced back to the offender. Audit trails are mandatory by law, as otherwise, how would violations of confidentiality be punished? In a medical emergency, a patient’s life may be threatened by the sudden and unexpected development of a health condition. High unpredictability and the requirement for expedited service delivery are characteristic of a medical emergency department. The need for efficiency raises challenges that require a balance between the right to life, efficiency and the protection of human dignity. The right to life and the right to dignity are enshrined in sections 10 and 11 of the SA Constitution, respectively.[17] Section 2.3(a) of the Patient’s Rights Charter states that everyone has the right to receive timely emergency care.[18] Members of the emergency team never know what to expect at any given point in time, resulting in feelings of anxiety.[19] When attending to multiple patients at the same time, overcrowding, high noise levels and fatigue may result in interruptions of the thinking and decision-making process.[20] These factors are cited in the literature as the leading cause of errors in diagnosis associated with clinical emergencies.[21] The need for efficiency in emergency departments induces stress in members of the emergency team. Individuals are likely to forget passwords that are long and contain a variety of characters, especially when working under stressful conditions.[6,22,23] Perhaps considerations regarding the right to life and timely access to emergency care inform some of the practices that result in the accessing of the PACS without requiring a password. Similar reasons may account for the 54% of PACS workstations that were not capable of automatic log-off, causing them to remain active all the time.

Conclusion This paper highlights the dilemma in emergency departments between the need for efficient patient treatment and respect for patient ethical rights. In a medical environment dominated by a culture of trust, human dignity may not be the primary concern, especially when competing with the supreme right to life. However, just because HPs are inclined to trust one another, based on the assumption that HPs are ethical beings who respect patient confidentiality, this does not mean that all HPs are trustworthy. There may be occasions when patients suspect that HPs may abuse their privileges of access to medical records.[24] The protection of patient data requires the fulfilment of diligent security measures, including the use of effective passwords and automatic computer log-off. These measures may be timeconsuming, and therefore not suitable for the levels of efficiency needed in emergency departments. The use of effective passwords is necessary to protect human dignity, the provision of which is enshrined in section 14(d) of the SA Constitution.[17] Yet, practices that are compliant with the minimum standards of effective passwords stand to threaten the supreme human right to life. In a medical emergency, seconds count. Computers take ~60 seconds to initialise and authenticate the user, excluding the additional time needed to process an image or to call up patient data.[25] Depending on the type of medical emergency, 60 seconds could mean

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the difference between organ impairment and death. Eliminating the time for computer initialisation and authentication could go a long way towards saving lives. At the time of this report, there were no data to suggest that lives have been lost as a result of computer initialisation and authentication. However, the lack of data does not mean that incidents have not occurred or will not occur in the future. It remains unclear whether compliance with the minimum standards for effective password usage is suitable to emergency departments. This article may have contributed to normative ethics in asking the question as to whether medical emergency departments ought to be an exception to the minimum standards of effective password usage. The reasons for non-compliance presented in this article are mere suggestions drawn from the literature. Future research is needed, firstly, to determine reasons for non-compliance specific to the use of PACS in an emergency department; and secondly, to determine alternative security measures that would aid in preserving patient confidentiality in such departments. Acknowledgements. This article presents the findings of a Master’s dissertation obtained through the University of Johannesburg. Both authors greatly appreciate the permission granted by the research settings and the contribution of the participants. Author contributions. TBM and BvD worked jointly in preparing and approving the article for submission. In her capacity as the primary researcher, TBM contributed to project design and data collection. BvD was the study supervisor, and made enormous contributions to the conceptual framework and editing of the manuscript. Funding. None. Conflicts of interest. None.

1. Dayarathna R. The principle of security safeguards: Unauthorized activities. Comput Law Secur Rev 2009;25(2):165-172. https://doi.org/10.1016/j. clsr.2009.02.012 2. Princely I. Understanding information security systems policy compliance: An integration of the theory of planned behaviour and the protection motivation theory. Comput Secur 2012;31(1):83-95. https://doi.org/10.1016/j. cose.2011.10.007 3. Steers K. Boot passwords, put your PC under lock and key. PC World 2003;21(9):168. 4. Stross R. Goodbye passwords, you aren’t a good defence. 8 October 2008. http:// www.nytimes.com/2008/08/10/technology/10digi.html (accessed 27 May 2017). 5. Jeffersen G. Forget passwords – use your face instead [press release]. USA: USA Today Edition; 1 May 2015. 6. Payton L. Memory for passwords: The effect of varying number, type and composition. Psi Chi J Undergrad Res 2010;15(4):209-213.https://doi. org/10.24839/1089-4136.JN15.4.209 7. Williams PAH. In a ‘trusting’ environment, everyone is responsible for information security. Inf Sec Tech Rep 2008;13(4):207-215. https://doi.org/10.1016/j. istr.2008.10.009 8. Robinson R. Moral distress. Dimens Crit Care Nurs 2016;35(4):235-240. https://doi. org/10.1097/dcc.0000000000000185 9. Mahlaola TB. Compliance of health professionals with patient confidentiality when using PACS and RIS. PhD thesis. Johannesburg: University of Johannesburg, 2013. https://scholar.google.co.za/citations?user=SxxS8R4AAAAJ&hl=en 10. Beach J, Oates J. Maintaining best practice in recordkeeping and documentation. Nurs Stand 2014;28(36):45-50. https://doi.org/10.7748/ns2014.05.28.36.45.e8835 11. Bolan C. A view of the future image exchange. Appl Radiol 2013;42(11):32-37. http://appliedradiology.com/articles/technology-trends-a-view-of-the-futureimage-exchange (accessed 24 October 2017). 12. Benatar D. Indiscretion and other threats to confidentiality. S Afr J Bioeth Law 2010;3(2):59-62. http://www.sajbl.org.za/index.php/sajbl/article/view/101/83 (accessed 24 Oct 2017). 13. International Organization for Standardization. Improved ISO/IEC 17799 makes information assets even more secure. https://www.iso.org/news/2005/06/Ref963. html (accessed 24 October 2017). 14. Daniel J. Sampling essentials: Practical Guidelines for Making Sampling Choices. Washington DC: SAGE Publications, 2012. https://doi.org/10.4135/9781452272047

ARTICLE 15. Health Professions Council of South Africa. Confidentiality: Providing and Protecting Information. Booklet 11. http://www.hpcsa.co.za/Uploads/editor/UserFiles/ downloads/conduct_ethics/rules/generic_ethical_rules/booklet_10_confidentiality_protecting_and_providing_information.pdf (accessed 2 October 2011). 16. Cao F, Huang HK, Zhou XQ. Medical image security in a HIPAA mandated PACS environment. Comput Med Imaging Graph 2003;27(2-3):185-196. https://doi. org/10.1016/s0895-6111(02)00073-3 17. Constitution of the Republic of South Africa, 1996. 18. Health Professions Council of South Africa. National Patients’ Rights Charter. Booklet 3. http://www.hpcsa.co.za/downloads/conduct_ethics/rules/generic_ ethical_rules/booklet_3_patients_rights_charter.pdf (accessed 10 July 2017). 19. Croskerry P, Cosby KS, Schenkel SM, Wears RL. Patient Safety in Emergency Medicine. Philadelphia: Wolters Kluwer Health, 2009. 20. Palmer LK. The relationship between stress, fatigue and cognitive functioning. Coll Stud J 2014;48(1):198-211. https://eric.ed.gov/?id=EJ1022296 (accessed 24 Oct 2017). 21. Luigi BP. Error risk in decision-making process. Emerg Care J 2014;10(1):37-40. https://doi.org/10.4081/ecj.2014.2119

22. Healy S, Tyrrel M. Stress in emergency departments: Experiences of nurses and doctors. Emerg Nurs 2011;19(4):31-37. https://doi.org/10.7748/en2011.07.19.4.31. c8611 23. Espana LY. Effects of password type and memory techniques on user password memory. Psi Chi J Psychol Res 2016;21(4)269-275. https://doi.org/10.24839/ b21.4.269 24. Akyüz E, Erdermir F. Surgical patients’ and nurses’ opinions and expectations about privacy in care. Nursing Ethics 2013;20,(660)e671. https://doi. org/10.1177/0969733012468931 25. Ganthan NS, Rabiah A, Zuraini I. Security threats categories in healthcare information systems. Health Inform J 2010;16(3):201-209. https://doi. org/10.1177/1460458210377468

Accepted 17 October 2017.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Do doctors attending sexual-offence victims have to notify sexual-offence suspects that their patients who were forced to have unprotected sexual intercourse are HIV-positive? What should doctors do? D J McQuoid-Mason, BCom, LLB, LLM, PhD Centre for Socio-Legal Studies, Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D J McQuoid-Mason (mcquoidm@ukzn.ac.za)

The question has been asked as to whether doctors attending sexual-offence victims have to notify sexual-offence suspects that their patients who were forced to have unprotected sexual intercourse are HIV-positive. It is submitted that the common law requires doctors to warn endangered third parties where such persons may suffer injury as a result of interactions with their patients, and that this applies to patients who have tested positive for HIV. The ethical rules of the Health Professions Council of South Africa also require doctors to breach the confidentiality rule against the consent of their patients who have tested HIV-positive, where the sexual partner of a patient is known, and after counselling such patients still refuse to allow disclosure – provided there is no risk of consequential harm to such patients. The dilemma of doctors treating HIV-positive patients is sometimes resolved where, in terms of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007, a court order for the compulsory testing of the suspect has been obtained and the suspect knows his or her HIV status. Recommendations are made for what doctors should do in such cases. S Afr J Bioethics Law 2017;10(2):67-69. DOI:10.7196/SAJBL.2017.v10i2.602

I was recently asked whether it is a doctor’s duty when attending to sexual-offence victims to notify suspected sexual-offence perpetrators that their patients who were forced to have unprotected sexual intercourse were HIV-positive. It was said that this question has arisen because there is no legislation or court case directly on the subject. The question, however, can be answered by examining: (i) the common-law duty to warn endangered third parties; (ii) the provisions of the Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007 (hereafter referred to as the Sexual Offences Act);[1] and (iii) the ethical rules and guidelines of the HPCSA.

Common-law duty to warn endangered third parties At common law, traditionally there was no general duty to act unless a person: (i) had created a dangerous situation through their prior conduct; (ii) was in control of a dangerous object; (iii) held public office; (iv) was in breach of a statute; or (v) was in a special relationship with another.[2] These categories were later expanded to include a wider test that imposed liability if the legal convictions of the community would have been outraged if the person in question failed to act.[2] Since the advent of democracy, the courts have indicated that the legal convictions of the community must be informed by the provisions of the Constitution.[3,4] While these categories provide useful guidelines, they are not fixed, and the courts tend to take a flexible approach.[2] The most useful approaches to determine whether or

not there is duty on doctors to inform suspects that their patients who were forced to have unprotected sexual intercourse with such suspects were HIV-positive are those of a ‘special relationship’ and ‘the legal convictions of the community as informed by the Constitution’.

Special relationship An example of a special relationship is the doctor-patient relationship, and the duty on doctors to treat their patients with the skill and care of a reasonably competent doctor in their branch of the profession.[5] There is also a special relationship between doctors and persons who are not their patients but who require emergency medical treatment.[6] It is submitted that doctors also have a special relationship with persons who may be harmed as a result of conduct by their patients, and that in such circumstances, doctors have a duty to warn endangered third parties who may be injured by their patients.[7] Therefore, where a doctor knows that his or her HIV-positive patient has had unprotected sexual intercourse with a known partner, there is a legal duty on the doctor to counsel the patient to warn such partner and to take precautions, failing which there is a duty on the doctor to warn the partner.[7] This duty is also provided for in the HPCSA guidelines[8] mentioned below. While the courts are not bound by the general practices and guidelines of the professions, they will usually give due weight to them when judging whether or not practitioners have acted as reasonably competent members of their profession would act.[5]

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ARTICLE Legal convictions of the community as informed by the Constitution The Constitution[3] provides that everyone has a right to bodily and psychological integrity (section 12(1)), and that nobody may be refused emergency medical treatment (section 27(3)). The nature of medical practice and the ethical obligations imposed on members of the profession by the HPCSA,[8] measured against the right to bodily and psychological integrity in the Constitution, can give an indication of what the legal convictions of the community would expect from doctors. Thus it can be argued that the legal convictions of the community, as informed by the Constitution,[3,4] would be outraged if a doctor, knowing of a patient’s HIV-positive status, did not inform the alleged perpetrator of a sexual offence, who was at risk of contracting HIV, that he or she should get tested to avoid compromising their bodily and psychological integrity. If the alleged perpetrator is HIV-negative and needs to be put on post-exposure prophylaxis (PEP) within 72 hours of the alleged offence, this can be regarded as a need for ‘emergency medical treatment’.[9] Likewise, therefore, it can be argued that the legal convictions of the community, as informed by the Constitution, would impose a legal duty on the doctor concerned to advise the alleged perpetrator to get tested within the 72-hour period.[9] In summary, therefore, it seems that at common law – whether applying the special-relationship principle or the legal convictions of the community, as informed by the Constitution, principle – a legal duty will be imposed on doctors treating HIV-positive victims of sexual offences to advise the alleged perpetrators to undergo an HIV test if their patients may have exposed the suspects to HIV infection.

Legal duties imposed under the Sexual Offences Act Most of the duties imposed under the Sexual Offences Act[1] (Section 36) and the National Instruction issued in terms of the act[10] by the National Commissioner of the South African Police Service protect the rights of the victims of alleged sexual offences. However, some provisions also protect the rights of alleged perpetrators, such as the right to confidentiality when a court order is granted compelling suspects to undergo HIV tests[1] (section 36) and when the results of the tests are known (section 37). In terms of the Sexual Offences Act,[1] an application may be made to a magistrate for the compulsory testing of an alleged sexual-offence perpetrator by the victim, or an interested person on their behalf (section 30(1)). Where the application for compulsory HIV-testing was made by the victim or an interested person, the investigating officer must hand the sealed record of the test results to such person and the alleged offender, which must be kept confidential. The officer must also provide the prescribed information on the confidentiality of, and how to deal with, the HIV results, and if necessary, explain their contents (section 33(1)). The act further provides that if an application for compulsory testing is made and the HIV status of the suspect is positive, the victim or the interested person acting on their behalf will be notified and will be able to discuss PEP with the victim’s examining doctor (section 28). The examining doctor is legally required to ensure that, where necessary, the victim receives free PEP at a public health establishment, as well as free medical advice concerning the administering of such PEP (section 28). This will include establishing whether the victim wishes to undergo an HIV test to decide whether

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or not she or he should engage in PEP treatment, and then liaising with the police regarding the support required for the victim. The police National Instruction[10] deals mainly with the duties of police officers in the context of victim assistance (section 5). It provides for the medical examination of the alleged perpetrator, but there is no mention of testing him or her for HIV, as this is dealt with in the compulsory-testing provisions of the Sexual Offences Act.[1] The medical examination of the suspect in the National Instruction is concerned with the collection of evidence from the body of the suspect, to establish his or her bodily features and to get blood samples for DNA analysis (section 16). Where no application has been made for the compulsory testing of the suspect and the victim tests positive for HIV, it is submitted that the victim’s examining doctor – if he or she is not the same doctor who examines the suspect – should inform the suspect’s examining doctor that such doctor should advise and counsel the suspect to undergo an HIV test if the latter does not know their HIV status. In summary, the provisions of the Sexual Offences Act[1] are of assistance when a compulsory HIV test has been ordered by the court, because both the alleged perpetrator and the victim will know the suspect’s HIV status. If the suspect’s HIV test is positive and the victim’s test is negative, she or he must be offered PEP and medical advice at state expense, and there is no need to inform the suspect. Conversely, it is submitted that if the victim’s HIV test is positive, and the suspect has not been subjected to a court-ordered HIV test and does not know his or her status, and the victim’s examining doctor is also the suspect’s examining doctor, such doctor needs to advise the suspect to undergo an HIV test, and if the result is negative, to take PEP. If the victim is HIV-positive, and the victim’s examining doctor is not also the suspect’s examining doctor, the former must advise the latter to counsel the suspect on the need for him or her to undergo an HIV test.

Ethical rules and guidelines of the HPCSA on HIV The ethical rules of the HPCSA provide a broad framework for ethical practice by practitioners registered with it.[8] In addition, the HPCSA has produced a series of booklets that provide guidance to practitioners by expanding on the provisions in the ethical rules. Booklet 11 covers Ethical Guidelines for Good Practice with Regard to HIV.[11] These guidelines state that ‘[t]he decision to divulge information relating to the HIV status of a patient must always be done in consultation with the patient’ (para 5.4). The guidelines, however, state that it is good clinical practice for health practitioners to encourage their HIV-positive patients to disclose their status to their sexual partners, so that the latter can get tested and access treatment if necessary (para 9.1). If patients refuse consent, healthcare practitioners should use their discretion in deciding whether or not to make such disclosure to their patients’ sexual partners ‘taking into account the possible risk of HIV infection to the sexual partner and the risks to the patient (e.g. through violence) that may follow such disclosure’ (para 9.2). In making the decision, health practitioners must consider the rights of all the parties concerned and take ‘full responsibility’ for their actions (para 9.2). The guidelines provide that the health practitioner must: (i) ‘[c]ounsel the patient on the importance of disclosing to his or her sexual partner and on taking other measures to prevent HIV transmission’; (ii) ‘provide

ARTICLE support to the patient to make the disclosure’; (iii) ‘[i]f the patient still refuses to disclose his or her HIV status or refuses to consider other measures to prevent infection, counsel the patient on the healthcare practitioner’s ethical obligation to disclose such information’; (iv) ‘[i]f the patient still refuses, disclose information on the patient’s HIV status to the sexual partner and assist them to undergo testing and access treatment if necessary’; and (v) must ‘[a]fter disclosure, follow up with the patient and the patient’s partner to see if disclosure has resulted in adverse consequences or violence for the patient, and, if so, intervene to assist the patient appropriately’ (para 9.2). These requirements can be applied to the need to disclose a patient victim’s HIV-positive status to a sexual-offence suspect who may have been exposed to HIV infection. It is submitted that the reference to a ‘sexual partner’ does not necessarily mean a person with whom the patient has had consensual sexual intercourse. The important requirement is that there must be an attempt to obtain the patient’s consent, and then, if it is refused, to engage in proper counselling of the patient before deciding to make disclosure without consent.

What should doctors do? Doctors should act in line with their common-law duty to protect endangered third parties – and to use the HPCSA guidelines – when deciding whether to disclose the HIV status of victims of sexual offences to suspects who have had unprotected sexual intercourse with HIV-positive victims. In such circumstances it is recommended that doctors should: (i) counsel HIV-positive victims who allege that suspects have had unprotected sexual intercourse with them and who refuse consent for the examining doctor to disclose their HIV status that doctors are ethically and legally obliged to advise such suspects to have an HIV test, and that if the test is negative, to advise the suspects to request PEP; (ii) inform suspects that the courts – and not the doctors – will decide on their guilt, but that if they have had unprotected sex with

the victim they are strongly advised to have an HIV test, and if the tests are negative such suspects should request PEP. Suspects can decide whether or not they wish to follow the advice of the doctors; and (iii) if the HIV tests of the suspects are negative, doctors should inform the SAPS that they need to ensure that such suspects are taken to clinics to undergo PEP treatment within 72 hours of the alleged offence. The police are obliged to do this because the courts have held that there is a legal duty on detaining authorities to provide the same level of care to persons in their custody as ordinary people who require antiretroviral treatment at public facilities.[12] Acknowledgements. None. Author contributions. Sole author. Funding. None. Conflicts of interest. None. 1. South Africa. Criminal Law (Sexual Offences and Related Matters) Amendment Act No. 32 of 2007. 2. Minister van Polisie v Ewels 1975 (1) SA 590 (A). 3. Constitution of the Republic of South Africa, 1996. 4. S v Makanyane 1995 (3) SA 391 (CC). 5. Van Wyk v Lewis 1924 AD 438. 6. McQuoid-Mason DJ. When are doctors legally obliged to stop and render assistance to injured persons at road accidents? S Afr Med J 2016;106(6): 575-577. https://doi.org/10.7196/samj.2016.v106i6.10503 7. Tarasoff v Regents of the University of California (1976) Cal S Ct, 17 Cal Rep 3rd series 425. 8. Health Professions Council of South Africa. Ethical and Professional Rules. Booklet 2. Pretoria: HPCSA, 2006. 9. McQuoid-Mason DJ, Dhai A, Moodley J. Rape survivors and the right to emergency medical treatment in order to prevent HIV infection. S Afr Med J 2003; 93(1): 41-44. 10. South African Police Service. National Instruction 3/2008 Sexual Offences. Government Gazette No. 31330, 15 August 2008. 11. Health Professions Council of South Africa. Ethical Guidelines for Good Practice with Regard to HIV. Booklet 11. Pretoria: HPCSA, 2008. 12. Van Biljon v Minister of Correctional Services 1997 (4) SA 441 (C).

Accepted 5 July 2017.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Transparency in medicines regulatory affairs – reclaiming missed opportunities Y A Vawda,1 BA, BProc, LLM, LLD; A Gray,2 BPharm, MSc (Pharm), FPS, FFIP 1 2

School of Law, College of Law and Management Studies, University of KwaZulu-Natal, Durban, South Africa Division of Pharmacology, Discipline of Pharmaceutical Sciences, University of KwaZulu-Natal, Durban, South Africa

Corresponding author: Y A Vawda (VAWDAY@ukzn.ac.za)

Transparency is a salutary value in South Africa (SA)’s constitutional architecture. It has also been described as a necessary element in promoting accountability in the regulatory aspects of essential medicines. Nevertheless, despite its several incarnations since its promulgation, the Medicines and Related Substances Act No. 101 of 1965 retains a ‘preservation of secrecy’ provision (section 34). This contribution seeks to evaluate section 34 in the context of transparency; to ascertain whether it is in conflict with other legislation pertaining to the promotion of access to information; and, in particular, to establish whether it is consistent with the Constitution of the Republic of SA. S Afr J Bioethics Law 2017;10(2):70-74. DOI:10.7196/SAJBL.2017.v10i2.607

Transparency is a salutary value in South Africa (SA)’s constitutional architecture.[1] It has also been described as a necessary element in promoting accountability in essential medicines selection, quality assurance, improvement of use, and priority setting for research and development.[2] One of the institutions providing an important public function in every country is the national medicines regulatory authority (NMRA). In SA, this function is in the process of being transferred from the Medicines Control Council (MCC) to the SA Health Products Regulatory Authority (SAHPRA). However, despite amendments in 1997,[3] 2002,[4] 2008,[5] and 2015,[6] the Medicines and Related Substances Act No. 101 of 1965[7] (Medicines Act) retains a provision headed ‘Preservation of secrecy’ (section 34). This brief review seeks to evaluate section 34 of the Medicines Act in the context of transparency, and to ascertain whether it is in conflict with other legislation pertaining to the promotion of access to information and, in particular, whether it is consistent with the Constitution of the Republic of SA (the Constitution).[1] In order to establish the constitutionality of this provision, it is necessary to explore the following series of linked questions: (i) What is the extent of the limitations on transparency in section 34 of the Medicines Act? (ii) Is section 34 so excessively broad as to infringe on the constitutional right to access to information? (iii) If so, can such an infringement be justified? (iv) Does section 34 amount to an undue prohibition of access to information that is in the public interest, as envisioned in the Promotion of Access to Information Act No. 2 of 2000 (PAIA)?[8]

The Constitution Any informed view of the statutory provision under scrutiny must consider the constitutional perspective. With regard to access to information, the relevant provision is section 32 of the Constitution,[1] which states:

‘(1) Everyone has the right of access to – (a) any information held by the state; and (b) any information that is held by another person and that is required for the exercise or protection of any rights.’ Given the supremacy of the Constitution, a provision in any law that is in conflict with it is unconstitutional, and therefore unlawful. The primacy of constitutional rights has been established in several court decisions. In S v Zuma,[9] these rights were given the most generous possible interpretation. The court made particular reference to the Canadian case of Regina v Big M Drug Mart Ltd.,[10] in which it was stated: ‘The meaning of a right or freedom guaranteed by the Charter was to be ascertained by an analysis of the purpose of such a guarantee; it was to be understood, in other words, in the light of the interests it was meant to protect.’ The constitutional perspective was further articulated in S v Makwanyane,[11] where the Constitutional Court emphasised a contextual approach to interpretation, which included reviewing the history and background of the Constitution, other provisions within it and the values it represents. However, constitutional rights are not absolute, and in limited circumstances can be infringed upon, without invalidating the offending provision. This principle is specifically provided for in section 36 (the limitation of rights clause)[1] which states: ‘(1) The rights in the Bill of Rights may be limited only in terms of law of general application to the extent that the limitation is reasonable and justifiable in an open and democratic society based on human dignity, equality and freedom, taking into account all relevant factors, including: (a) the nature of the right; (b) the importance of the purpose of the limitation; (c) the nature and extent of the limitation; (d) the relation between the limitation and its purpose; and (e) less restrictive means to achieve the purpose.’

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ARTICLE In view of the significance of rights and the protections they afford, if any provision appears to infringe upon a right it is prima facie unconstitutional, and therefore the duty rests on the infringing party to demonstrate that it has satisfied the test elaborated in section 36, as stated in S v Makwanyane.[11] In making the determination of whether an infringement is justified, the Canadian court in R v Chaulk[12] set out the reasonable limit test following the case of R v Oakes,[13] which held that the objective of the infringement must be of sufficient importance, the means being used must be rationally connected to the objective, it should impair rights as minimally as possible and the effects of the limitation should be proportional to the objective. While South African constitutional jurisprudence shares many features with its Canadian counterpart, such as a twostage limitations analysis, it has not adopted the reasonable limit test, opting instead for a multifactor balancing approach. This confers a wide discretion on the courts, enabling them to sometimes adopt a test for rationality (deciding whether the limitation is reasonable) and, at other times, a test for reasonableness (considering rationality and proportionality).[14] Section 32 makes specific reference to information held by the state. In deciding whether the MCC or SAHPRA is an ‘organ of state’, recourse must be had to section 239[1] of the Constitution, which reads: ‘Organ of state’ means (a) any department of state or administration in the national, provincial or local sphere of government; or (b) any other functionary or institution: (i) exercising a power or performing a function in terms of the Constitution or a provincial constitution; or (ii) exercising a public power or performing a public function in terms of any legislation, but does not include a court or a judicial officer.’ As institutions performing a public function in terms of legislation, namely the Medicines Act, both qualify as organs of state, and consequently are subject to the obligations placed on them by the Constitution and other legislation. In addition, SAHPRA has been designated as a schedule 3A national public entity in terms of the Public Finance Management Act No. 1 of 1999.[15]

The Promotion of Access to Information Act Section 32 is a key provision in the Constitution, as it has been held that access to information is crucial to the right of freedom of expression, and that the public must have access to information held by the state.[14] The right to access to information in section 32 of the Constitution is given effect to in section 9 of PAIA,[8] which deals with the objects of the Act: ‘(a) to give effect to the constitutional right of access to (i) any information held by the state; and (ii) any information that is held by another person and that is required for the exercise or protection of any rights’. PAIA is premised on the notion that access to information is essential to a liberal constitutional democracy, because transparency of state entities and public bodies promotes accountability and deters corruption and the abuse of power. For this reason, it endeavours to provide for access to any information held by the state, as opposed to access to information held by private bodies, which is limited

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to instances for the exercise and protection of any rights. This is reinforced by the strong and definitive wording of section 11 of PAIA,[8] dealing with public bodies, which provides that: ‘(1) a requester must be given access to a record of a public body if: (a) that requester complies with all the procedural requirements in this Act relating to a request for access to that record; and (b) access to that record is not refused in terms of any ground for refusal contemplated in Chapter 4 of this Part.’ (emphasis added). In certain instances, there is a justifiable interest in protecting information held by public bodies from being disclosed. Such instances are dealt with in Chapter 4 of Part 2 of PAIA, pertaining to the grounds of refusal of access to records, which prescribes the grounds both upon which an information officer of a public body must refuse, as well as instances where he may refuse, a request to access a record. Therefore, section 43 provides for the mandatory protection of the research information of a third party, and may require the protection of such information relating to a public body. These protections must, however, be weighed against section 46,[8] which deals with mandatory disclosure in the public interest, and which states: ‘Despite any other provision of this Chapter, the information officer of a public body must grant a request for access to a record of the body contemplated in [various sections listed] if – (a) the disclosure of the record would reveal evidence of – (i) a substantial contravention of, or failure to comply with, the law; or (ii) an imminent and serious public safety or environmental risk; and (b) the public interest in the disclosure of the record clearly outweighs the harm contemplated in the provision in question.’ An NMRA is required, for instance, by Article 39 of the World Trade Organization’s agreement on Trade-Related Aspects of Intellectual Property Rights to protect undisclosed trial data against ‘unfair commercial use’, ‘except where necessary to protect the public’.[16] The decision in SA Airlink v Mpumalanga Tourism and Parks Agency[17] illustrates the manner in which the courts have dealt with competing interests when considering the issue of access to information. The court held that, where a state body seeks to refuse access to information to the public, the burden rests on the person refusing access to establish that the refusal is justified under PAIA.[17] The court also considered refusal to grant access to information where doing so would be likely to cause harm to the commercial and financial interests of a third party. On this issue, the court held that in order for such a refusal to be justified the harm must not only be possible, but probable. In other words, it is not sufficient for a body to refuse to disclose information because there is some chance of harm to a third party, no matter how remote, as this would constitute an arbitrary infringement of a fundamental right. In order for state bodies to refuse to disclose information on the basis of a possible harm or setback to a third party, the duty is on the person refusing to show why this harm is serious and likely to materialise. The court also held that the mere existence of a confidentiality clause in an agreement ‘cannot shield the agreement from disclosure’.[17] Furthermore, refusals cannot be justified by the mere fact that the requests made were too broad, as was held in the case of Biowatch Trust v Registrar Genetic

ARTICLE Resources and Others.[18] If the state body in question is of the opinion that a request is not sufficiently specific, it is under an obligation to assist the person who made the request in identifying the document or documents sought. It cannot simply dismiss requests and so deny a right to access to information on the grounds of ambiguity of the request, and there is a positive onus upon the state body to make a bona fide effort to clarify the information the requester is seeking, failing which the refusal will be unjustified. In this case, the court expressed a similar sentiment to that in the SA Airlink case regarding refusals. It stated that although confidentiality of information and potential violation of third parties’ rights are legitimate concerns, they cannot serve as grounds to bar access to all requested information.[18]

Section 34 of the Medicines Act Section 34 of the Medicines Act[7] provides that: ‘No person shall, except for the purpose of the exercise of his powers or the performance of his functions under this Act, or for the purpose of legal proceedings under this Act, or when required to do so by any competent court or under any law, or with the written authority of the Director-General, disclose to any other person any information acquired by him in the exercise of his powers or the performance of his functions under this Act and relating to the business or affairs of any person, or use such information for self-gain or for the benefit of his employer.’ The wording in this section is peremptory, particularly the use of the word ‘shall’, and does not permit any disclosure of information except when specifically authorised by the Act. The purpose of this provision appears to be to prevent persons who work for and perform some function within the MCC (and now SAHPRA) from disclosing to unauthorised persons the information they gather in the course of their work, and from using such information for their own gain or profit. This, in itself, is perfectly rational, considering the sensitive nature of some of the information such persons might have access to, and for the risk of serious prejudice that such disclosure could cause to the persons and bodies to which the information pertains. The major concern for any NMRA is to protect information that is considered ‘commercial in confidence’, and therefore not to be revealed, on account of the potential damage to the commercial entity that has provided such information to the regulator for the purpose of obtaining registration of a medicine or medical device. In this regard, the recommendations of the US and European authorities on what should not be considered privileged information are instructive. Among the recommendations of the Blueprint for Transparency at the US Food and Drug Administration (FDA) are that the regulator routinely disclose basic information about the filing of applications for marketing authorisation, including for generic medicines, and the existence of clinical holds on clinical trials.[19] In particular, it is recommended that the FDA ‘[m]ake pooled data sets, masked and deidentified as appropriate, and the FDA’s analyses of these data sets, available to the medical and research community through clinical data repositories’.[19] Such analyses have traditionally been regarded as confidential, and not to be disclosed to any party other than the applicant for marketing authorisation. The European Medicines Agency (EMA) has noted the ‘growing demand from stakeholders for additional transparency, not only about the Agency’s deliberations and actions, but also about the clinical data on which regulatory decisions are based’.[20]

The reference to ‘self-gain’ and ‘benefit’ indicates that the legislature had contemplated that such information would have value to other parties such as competitors. The purpose of this provision is therefore to protect parties who submit sensitive and potentially valuable information to the NMRA when seeking regulatory approval from suffering prejudice through unauthorised disclosure. However, the provision appears to have overlooked the significant public-health interests that might be advanced by ensuring timely access to such information. In enacting section 34 of the Medicines Act, it appears that the legislature intended to take a firm stance regarding unauthorised use of information. The provision is therefore drafted in broad terms to prevent any circumvention or liberal interpretations that would allow those who would breach this provision to escape the appropriate sanction. Section 34 appears to provide the MCC/SAHPRA with broad discretion to refuse access to information, with the exception of the limited grounds mentioned therein. Significantly, the MCC/SAHPRA is not required to provide any justification for its refusal to accede to any request for information. The temptation is therefore to apply this provision in a blanket manner, and opt not to place any information that is in the slightest part useful to a competitor, such as the fact that an application for registration has been lodged, in the public domain. Another default position is to fail to provide the scientific basis for regulatory decisions, including analyses and findings with regard to clinical evidence of safety and efficacy. Communication is often limited to the minimum information mandated by section 22 of the Medicines Act,[7] and that required to be published in the register of medicines. There is a legitimate public interest in knowing whether an application for a particular medicine or medical device is being considered by the NMRA, as well as the detailed justification for either positive or negative decisions with regard to such an application.

A comparison of section 34 with similar provisions in other jurisdictions The African Union Model Law on Medical Products Regulation

It is useful to compare section 34 of the Medicines Act with another, similar provision, article 34 of the African Union Model Law on Medical Products Regulation[21] (the Model Law), which states that: ‘1) No person shall disclose to any other person or institution any information acquired by him in the exercise of his powers or the performance of his functions under this Law and relating to the business or affairs of any person, or use such information for self-gain or the benefit of his employer. A person may be permitted to disclose information: (a) for the purpose of the exercise of his powers or the performance of his functions under this law with the written authority of the agency/authority (b) when required to do so by any competent court or under any law, or (c) if it is in the public interest.’ This provision, like section 34 of the Medicines Act, prohibits the unauthorised disclosure of information, but contains a few key distinctions. The first difference is the seemingly minor addition of ‘or institution’ following the prohibition of unauthorised disclosure to any other person. The effect of this is to extend the reach of the

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ARTICLE provision so that it applies not only to disclosure to persons but any other institution that may not fall into the category of natural or juristic persons. The most significant difference between these two provisions is contained in section 2(c) of article 34. This subsection incorporates a qualification to the refusal of access to information, and refers directly to the public interest. The effect of this is that unlike in section 34 of the Medicines Act, article 34 of the Model Law requires all refusals to be balanced against the public interest, similar to the provisions of section 46(d) of PAIA.[8] The implication of this provision is that there can be no refusal if disclosure is in the public interest, and consequently, that the refuser will have to satisfy this requirement. No such justification is required under section 34 of the Medicines Act. Following its adoption by the African Union, member states are obliged to take steps to domesticate the Model Law by, for example, bringing domestic legislation in line with the principles entrenched in the Model Law.

European Medicines Agency transparency policy The EMA has adopted a proactive approach to enhancing transparency by issuing a policy on publication of clinical data for medical products for human use.[20] The policy was designed primarily to promote access to information held by the medicines regulator through an online database that is publicly accessible. As stated in the policy: ‘The Agency is committed to continuously extend its approach to transparency and has, therefore, taken the initiative to develop a policy on publication of clinical data’.[20] The policy relates to clinical data, composed of clinical reports and individual patient data. Nonetheless, the policy provides for the appropriate protection of information it categorises as ‘commercially confidential information’, defined as ‘any information contained in the clinical reports submitted to the Agency by the applicant that is not in the public domain or publicly available, and where disclosure may undermine the legitimate economic interest of the applicant’.[20] Accordingly, such information is not published, and is redacted from published documents where necessary. Despite this approach, the policy has been challenged in the European courts,[22] and remains contested.[23]

The UK Freedom of Information Act Section 1 of the UK Freedom of Information Act of 2000[23] states that: ‘(1) Any person making a request for information to a public authority is entitled – to be informed in writing by the public authority whether it holds information of the description specified in the request, and if that is the case, to have that information communicated to him.’ In contrast to section 34 of the Medicines Act, this provision places emphasis on access to information. It makes mandatory the disclosure of information subject to a request to a public body, and requires the public body to state whether it has the relevant information. These requirements facilitate transparency in relation to information held by public bodies.

The US Federal Food, Drug, and Cosmetic Act Section 301(j) of the Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938,[24] the statute that regulates the US NMRA, the Food and Drug Agency (FDA), prohibits:

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‘ The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of section 404, 409, 412, 414, 505, 510, 512, 513, 514, 515, 516, 518, 519, 520, 571, 572, 573, 704, 708, 721, 904, 905, 906, 907, 908, 909, or 920(b) concerning any method or process which as a trade secret is entitled to protection; or the violating of section 408(i)(2) or any regulation issued under that section.’ This provision, similarly to section 34 of the Medicines Act, prohibits persons using information that they acquire as a consequence of their authority in the agency for their own advantage or any other unauthorised disclosure. Despite this, it does not act as a blanket prohibition on the disclosure of all information to third parties, but specifically refers to information that is entitled to protection under the Act as a trade secret. This would appear to allow for the disclosure of information where it would be in the public interest, provided it did not include such specifically protected information. Accordingly, although often heavily redacted, the FFDCA places considerable resources in the public domain, including detailed accounts of deliberations of the advisory committees that inform decisions of the FDA. Together with a wide range of stakeholder groups, the FDA adopted the Blueprint for Transparency at the FDA, and provides for greater transparency of information held by the regulator, as alluded to above.[19] In response to concerns about research-participant confidentiality, the blueprint calls for the following approach: ‘When clinical-trial data, including patient-level data, are not available to independent investigators through industry-sponsored websites, make data available through clinical-data repositories, with policies on deidentification to protect patient privacy.’

Analysis of authorities Section 32 of the Constitution entrenches access to information as a fundamental right.[1] PAIA places great emphasis on access to information as a cornerstone of the transparency of state entities and public bodies.[8] The right to access to information, among others, seeks to make a clean break from the abuse of state power characterised by the apartheid system. This explains PAIA’s insistence on providing access to any information held by the state, as opposed to access to information held by private bodies. Given the gravity attached to the right of access to information in the context of public bodies, where such access is refused it must be for a specified and clear reason that is not outweighed by the ‘public interest’, as required by section 46.[8] Moreover, the refuser bears the onus of demonstrating that the refusal is justified under the law. Section 34 of the Medicines Act therefore appears to be in conflict with the values and rights entrenched in the Constitution and, more particularly, PAIA. This section, in effect, appears to grant the MCC/ SAHPRA unfettered authority to refuse access to information, except on limited grounds, based on its sole discretion. The limitation clause in the Constitution provides that any limitation of a right must be reasonable and justifiable. Applying the reasonable-limit test to section 34, it is clear that, while limiting access to information where it would advance personal interests is relevant, and the decision to refuse access to information is rationally connected to the objective of prohibiting unauthorised access to information, the broadness of section 34 impairs

ARTICLE the right of access to information to a greater extent than is absolutely necessary and justifiable. Section 34 has its genesis in the predemocracy legislation, and clearly does not take into account the constitutional paradigm. Its effect is to deprive the public of access to key information that may be of benefit to society, and gives the MCC/SAHPRA unfettered discretion to deny such access without the requisite openness and transparency required by the Constitution. The restrictions placed on access to information are therefore disproportional to the interest of preventing harm to third parties. The principle of constitutional validity of legislation was visited by the Constitutional Court in SANDU [SA National Defence Union] v Minister of Defence.[24] The court had to decide whether a provision prohibiting members of the national defence force from being members of trade unions was constitutional. In reaching its conclusion, the court set out the following test for examining whether or not a particular law is unconstitutional: ‘The first question to be asked is whether the provision in question infringes the rights protected by the substantive clauses of the Bill of Rights. If it does, the next question that arises will be whether that infringement is justifiable. At the second stage of the Constitutional inquiry, the relevant questions are what is the purpose of the impugned provision, what is its effect on Constitutional rights and is the provision well-tailored to that purpose.’[24] The court held that the relevant provisions contained ‘a sweeping prohibition, whose consequence is a grave incursion on the fundamental rights of soldiers. The provisions cannot be justified by reference to the need to ensure that uniformed military personnel do not engage in politically partisan conduct’.[24] It held that the prohibition, despite being connected to a rational end (the need to ensure that uniformed military personnel do not engage in politically partisan conduct) was not sufficient to justify the infringement of their rights. The court accordingly found that the provisions were inconsistent with the Constitution.

Conclusion Despite multiple opportunities having arisen to revise the law, section 34 of the Medicines Act, a provision that encroaches on a fundamental right entrenched in the Bill of Rights, without the requirement to provide any justification, remains in effect. In light of the emphasis on transparency and accountability in both the Constitution and PAIA, it is suggested that such a blanket provision barring access to information would not pass muster as a ‘limitation that is reasonable and justifiable in an open and democratic society based on human dignity, equality and freedom’.[1] It is accordingly submitted that section 34 of the Medicines Act is unconstitutional, to the extent that it violates the right to access to information in section 32 of the Constitution of SA, and should be amended in an appropriate manner to accommodate the fundamental right to access to information. It is therefore recommended that the following measures be implemented: (i) Section 34 should be amended to reflect the language and spirit of article 34 of the AU Model Law. (ii) This should be supplemented by the appropriate guidelines on commercially confidential information, as elaborated above, and the inclusion of a positive obligation on the MCC/SAHPRA to maximise transparency, while allowing applicants the right to

motivate what should be considered as commercially confidential information. (iii) Finally, these legislative changes should ensure alignment with the provisions of PAIA and, in particular, the conditions and processes related to applications for access to information. This is particularly important now that the 2008[5] and 2015 Medicines Amendment Acts[6] have been promulgated,[25] and a new model of medicines regulation is being implemented. It provides an opportunity to redress a serious anomaly in our regulatory framework, and to align it with our constitutional paradigm, in order to reflect greater openness, transparency and accountability in our public institutions. Acknowledgements. None. Author contributions. Equal contributions. Funding. None. Conflicts of interest. The authors are serving members of the Medicines Control Council of South Africa, and write in their personal capacities. 1. South Africa. The Constitution of the Republic of South Africa, Act No. 108 of 1996. 2. Wirtz VJ, Hogerzeil HV, Gray AL, et al. Essential medicines for universal health coverage. Lancet 2017;389(10067):403-476. https://doi.org/10.1016/s01406736(16)31599-9 3. Medicines and Related Substances Control Amendment Act 90 of 1997. 4. Medicines and Related Substances Amendment Act 59 of 2002. 5. Medicines and Related Substances Amendment Act 72 of 2008. 6. Medicines and Related Substances Amendment Act 14 of 2015. 7. Medicines and Related Substances Act 101 of 1965, as amended. 8. South Africa. Promotion of Access to Information Act No. 2 of 2000. 9. S v Zuma and others 1995 (2) SA 642 (CC); 1995 (4) BCLR 401 (CC). 10. Regina v Big M Drug Mart Ltd; 1985 (1) SCR 295. 11. S v Makwanyane and Another (CCT3/94); 1995 ZACC 3. 12. R v Chaulk; 1990 (3) SCR. 13. R v Oakes; 1986 1( )SCR 103. 14. Brummer v The Minister of Social Development and Others (CCT 25/09); 2009 ZACC 21. 15. South Africa. Public Finance Management Act No. 1 of 1999. 16. World Trade Organization. Agreement on Trade-Related Aspects Intellectual Property Rights. Geneva: WTO, 1995. 17. SA Airlink (PTY) Ltd v Mpumalanga Tourism and Parks Agency (01011/12) ZAGPHC 143. 18. Trustees For The Time Being of the Biowatch Trust v Registrar Genetic Resources and Others (23005/2002); 2005 ZAGPHC 135. 19. Sharfstein JM, Stebbins M. Enhancing transparency at the US Food and Drug Administration: Moving beyond the 21st Century Cures Act. JAMA 2017;317(16):1621-1622. https://doi.org/10.1001/jama.2017.2481 20. European Medicines Agency. EMA policy on publication of clinical data for medicinal products for human use (EMA/240810/2013). 2014. http://www.ema. europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf (accessed 8 July 2017). 21. African Union. AU Model Law on Medical Products Regulation, 2016. http://www. nepad.org/resource/african-union-au-model-law-medical-products-regulation (accessed 1 July 2017). 22. PTC Therapeutics International v EMA (T-718/15 R). 23. Kim D. Transparency policies of the European Medicines Agency: Has the paradigm shifted? Med Law Rev 2017;25(3):456-483. 24. United Kingdom. UK Freedom of Information Act 2000 http://www. legislation.gov.uk/ukpga/2000/36/pdfs/ukpga_20000036_en.pdf (accessed 8 July 2017). 25. United States of America. US Federal Food, Drug and Cosmetic Act 1938 https://legcounsel.house.gov/Comps/Federal%20Food,%20Drug,%20And%20 Cosmetic%20Act.pdf (accessed 8 July 2017). 26. SANDU v Minister of Defence (CCT27/98) 1999 ZACC 7. 27. South Africa. Proclamation Notice 20 of 2017, Government Gazette No. 40869. 2017.

Accepted 2 November 2017.

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This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

ARTICLE

Centre for Applied Ethics, Department of Philosophy, Faculty of Arts and Social Sciences, Stellenbosch University, Cape Town, South Africa Centre for Biomedical Ethics and Law, Department of Public Health and Primary Care, Faculty of Medicine, KU Leuven, Belgium

Corresponding author: C Ewuoso (19667876@sun.ac.za)

Background. This study forms part of an ongoing research project that seeks to enhance the information-management skills of health professionals within the clinical context. Objectives. To review case analyses and reviews and argument-based articles that use evidence and facts to prove whether or not a thesis is true. Specifically, this study attempts to provide a comprehensive overview of how health professionals manage information and related ethical challenges within the clinical context. Method. We carried out a literature search in PubMed and PhilPapers, using two search strings. All searches generated 954 hits. After screenings for year of publication, language, title and abstracts, duplicates and full-text reading, three more articles were identified following a system update in PubMed. A total of 53 articles were finally included for review. We used the Q-sort technique for the analysis of identified articles. Results. This review of concept- or argument-based articles and case analyses shows that there are five broad types of challenges – communication related, confidentiality related, professional-duty related, value-differences related and treatment-plan related; and four broad strategies – consultation, negotiating differences, using professional/prudential judgement and striving towards resolution – for managing these ethical challenges, in 21 fields of practice within the clinical context. Conclusion. This study greatly complements efforts aimed at providing a comprehensive overview of how health professionals manage information and related ethical challenges within the clinical context. Specifically, this study has identified four broad suggested strategies which may be employed to address the different challenges that can act as obstacles to communication within the clinical context. Further research is, however, needed to study whether these suggested strategies would indeed enhance communication and fiduciary relations between health professionals and patients. S Afr J Bioethics Law 2017;10(2):75-82. DOI:10.7196/SAJBL.2017.v10i2.610

This study is part of an ongoing project that is focused on enhancing health professionals’ skills in managing the ethical challenges around information management in health professionalpatient consultative encounters. Information management, following Swaminath,[1] is here taken to mean the power of a health professional to control the information that is disclosed to or withheld from patients. It is not always clear how information should be managed within the clinical context – for example, whether one should disclose or not disclose it, or whether one should tell the truth, or lie or conceal information. Certain guidelines, such as the Australian Code of Conduct for Doctors,[2,3] generally require physicians, for example, to disclose full and accurate information that has significant welfare implications, whether health-related or psychological, to their patients. Such disclosure, it is believed, would greatly strengthen patients’ autonomy and significantly enhance their informed decision-making capacity. This obligation is a matter of ethics and law.

Other guidelines, such as the Health Professions Council of South Africa’s Guidelines for Good Practice in the Healthcare Professions (Booklet 4 (3:3))[4] exist, which permit a physician to withhold information in circumstances where disclosure is medically contraindicated. Disclosure is medically contraindicated if it would cause a depressed patient, for example, to become actively suicidal, or compromise a patient’s recovery process, for example, telling a hypertensive patient receiving critical care in an intensive-care unit that his/her spouse has just died. Notwithstanding the above, certain clinical situations still exist – such as when information regarding misattributed paternity is accidentally discovered in a health professional-patient consultative encounter – where deciding what course of action to take (disclosure or non-disclosure) may prove extremely difficult. On the one hand, disclosure of misattributed paternity information when a patient has not requested such information (and where establishing paternity is not the purpose of the patient’s clinical interaction with the

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ARTICLE

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This study will focus exclusively on concept- or argument-based articles and case analyses or reviews. Only articles that studied any of the following were included: how health professionals manage information within any clinical context; the ethical challenges faced by health professionals around information management within any clinical context; and how these health professionals manage such challenges or ethical dilemmas within any clinical context. Excluded from this review were empirical studies, letters, reports, dissertations and guidelines. Article selection was conducted by the first author and discussed with the co-authors to ensure consistency of selection criteria. Finally, the articles which met our selection criteria were pooled together in EndNote database (version X6; Thomson Reuters, Canada). Articles were excluded after screening for: year of publication (we limited our search to articles published between 2004 and 2017), whereby 107 articles were excluded; an English language requirement (42 articles excluded); based on title and abstracts (628 articles excluded); duplication (42 articles excluded); upon reading the full text, 85 other articles were found to be irrelevant to our research aim, and thus excluded. A total of 50 articles were included for review after this process. Three more studies that met our criteria were further identified in PubMed following a system update, giving us a total of 53 studies that were finally included for review (Table 1 and Fig. 1).

Data extraction process Articles included for review were conventionally analysed to extract data. Consistent with the previous systematic review of empirical studies[5] this study used the Q methodological approach to conduct this review. The Q-sort technique is designed for qualitatively sorting a number of individual viewpoints into broader categories by identifying similarities. This approach can show how viewpoints or expressed opinions are interconnected or related. As Watts and Stenner[8] have observed, this is primarily an exploratory technique. Its aim is not to prove hypotheses. It can, however, bring a sense of coherence to individual research questions that have many, potentially complex and socially contested, answers. In Literature search

Searches were conducted in PubMed on 16 January 2017 and 23 January 2017 for concept- or argument-based articles, as well as case analyses, that focus on how healthcare professionals manage information and related ethical challenges within clinical context. Search strings – using a methodological approach for designing search strings and conducting a literature search developed by Pillastrini et al.[7] – were developed for our search for relevant materials. This methodological approach involves: framing a research question; looking up Medical Subject Heading (MeSH) terms for the components which make up the research question; reading published literature for alternative terms; and finally, combining these MeSH terms with Boolean operators (AND, OR, and NOT) in a database to deliver powerful, precise and relevant articles. For example, when we looked up the MeSH terms for ‘clinical challenge’, we found terms such as ‘ethical dilemma’, ‘moral conflicts’ and ‘truth-telling’, among others. The MeSH terms, rather than the term ‘challenge’, were then used to

Inclusion and exclusion criteria

Eligibility and screening

Methods

develop the search strings. These search strings generated 830 hits. An additional search, using a broad search string, was conducted in PhilPapers on 7 February 2017, and generated 124 hits, making a total of 954 hits.

Included

physician) may be taken by the patient as a violation of his/her right not to know; on the other, non-disclosure could be taken as a violation of patient’s right to know. In our earlier systematic review of empirical studies,[5] we discovered that healthcare professionals generally employ four broad strategies for managing four broad types of ethical challenges relating to information management. The four types of challenges are confidentiality related, communication related, professional-duty related and decision-making related. The challenge-management strategies are resolution, consultation, stalling and disclosure/ concealment. To gain a more comprehensive understanding of how healthcare professionals manage ethical challenges regarding information, the broad types of challenges health professionals face within the clinical context and the strategies they employ to address those challenges, we decided to embark upon a review of concept- or argument-based articles and case reviews or analyses, leading to this second study. In other words, we believe that a review of such articles will increase our knowledge of how healthcare professionals manage ethical challenges regarding information within the clinical context. In light of the above information, this present review is significantly different from the first study, in that the studies reviewed are different. However, the research questions are the same in both studies. As in our review of empirical studies, this present review is concerned with the research question: ‘How do healthcare professionals manage ethical challenges regarding information in health professionalpatient clinical interactions?’ The term ‘health professional’ is defined by the International Standard Classification of Occupations (ISCO)[6] as including generalists and specialist practitioners, pharmacists, nurses and dentists. What types of ethical challenges regarding information do concept- or argument-based articles and case reviews or analyses report that clinicians face within the clinical context? How do these clinicians address these ethical issues? These are some of the specific questions which could be derived from the research question. We have not found any published systematic review of such articles that has considered the research question posed in this study. Therefore, it is safe to say that this is the first systematic review of concept- or argument-based articles and case analyses to consider this research question. The eligibility criteria are provided in the next section.

Database search total

N=954

PubMed (narrow string) PubMed (broad string) PhilPapers

n=60 n=770 n=124

Articles excluded after title/abstract screening, total 954 – 42; n=628 PubMed (narrow string) n=13 PubMed (broad string) n=528 PhilPapers n=87

Total included for review: 284 – 42 (duplicates) – 107 (year of publication) – 85 (full-text screening) n=50 New articles after system update n=3 N=53

Fig. 1. Article selection process.

Articles excluded after language screening n=42 PubMed (narrow string) PubMed (broad string) PhilPapers

n=1 n=41 n=0

Articles entered into EndNote

n=284

Duplicates removed Excluded on year of publication Excluded after full-text screening

n=42 n=107 n=85

ARTICLE Table 1. Literature search – search strings used to conduct searches for relevant articles in PubMed and PhilPapers Search Date: 16 January 2017 Selected Restrictions: no restriction selected Search Mode: Default mode: sort by relevance Search String: ((((dilemma AND information)) AND (ethic OR ethics OR ethical OR moral)) AND (disclosure OR concealment OR “non disclosure” OR reporting OR returning OR “truth telling” OR recontacting OR withholding OR communicat*)) AND (intern OR surgeon OR nurse OR Allied Health Personnel OR caregiver OR dentist OR pharmacist OR geneticist OR “genetic counsellor” OR oncologist OR physician OR “general practitioner” OR “foreign medical graduate” OR resident OR anatomist OR psychiatrist OR “clinical scientist” OR GP) Hits:60 Database: PubMed Choose search number: Second search Search Date: 23 January 2017 Selected Restrictions: no restriction selected Search Mode: Default mode: sort by relevance Search String: (((((ethic OR ethics OR ethical OR moral)) AND (clinic or clinical)) AND (dilemma OR complex* OR conflict)) AND (disclosure OR concealment OR “non disclosure” OR reporting OR returning OR recontacting OR withholding OR communicat*)) AND (intern OR surgeon OR nurse OR Allied Health Personnel OR caregiver OR dentist OR pharmacist OR geneticist OR “genetic counsellor” OR oncologist OR physician OR “general practitioner” OR “foreign medical graduate” OR resident OR anatomist OR psychiatrist) Hits:770 Database: PhilPapers Choose search number: Additional search Search Date: 07 February 2017 Selected Restrictions: no restriction selected Search Mode: Default mode: sort by relevance Search String: “ethical dilemma” “healthcare professionals”; ethics “ethical dilemma” “Moral dilemma” dilemmas intern, surgeon, nurse, dentist, pharmacist, geneticist, oncologist, physician, psychiatrist Hits:124 Database: PubMed Choose search number: Additional search for new articles due to system update Search Date: 02 September 2017 Selected Restrictions: no restriction selected Search Mode: Default mode: sort by relevance Search String: ((((dilemma AND information)) AND (ethic OR ethics OR ethical OR moral)) AND (disclosure OR concealment OR “non disclosure” OR reporting OR returning OR “truth telling” OR recontacting OR withholding OR communicat*)) AND (intern OR surgeon OR nurse OR Allied Health Personnel OR caregiver OR dentist OR pharmacist OR geneticist OR “genetic counsellor” OR oncologist OR physician OR “general practitioner” OR “foreign medical graduate” OR resident OR anatomist OR psychiatrist OR “clinical scientist” OR GP) Hits: 3 new articles identified

summary, it is a useful technique for identifying common themes and sorting them into broad categories. Individual narratives may be used to supplement interpretation or understand the reason behind the sorted categories or themes.[8,9] We adopted this methodological approach for its vertical and horizontal usefulness. On the vertical line, it is a useful way for proceeding from a clearly defined research question to method, results and discussion. The research question plays a very important part in any Q methodological study, since it dictates the nature and structure of the themes or categories to be generated. On the horizontal line, it is a good approach for generating broadly representative opinions or viewpoints expressed by the authors of the reviewed studies as to what constitute the ethical challenges regarding information in health professional-patient interactions. This methodological approach was used in ATLAS.ti (Scientific Software Development GmbH, Germany) to highlight the broad types of ethical challenges faced by health professionals within the clinical context, as well as strategies and approaches for managing them. We highly recommend ATLAS.ti for the careful qualitative analysis of texts and data. It is a useful tool for managing a large volume of data in creative, yet systematic ways. Our eligibility criteria have pooled 27 case analyses and reviews, and 26 concept- and argument-based articles, for this review (Table 2).

Results

Challenges This review of concept- or argument-based articles, and case reviews or analyses, identified five principal challenges health professionals face within the clinical context. The challenges are communication related, confidentiality related, professional-duty related, valuedifferences related and treatment-plan related. Some subthemes that emerged under communication-related challenges include questions as to what to disclose, and who should disclose it.[10-13] For example, when incidental findings are discovered, the reviewed studies show that professionals often struggle with questions about how much should be disclosed (all incidental findings, only information with personal significance, only incidental findings with clinical significance, etc.), whether relatives should be contacted, especially if the condition is hereditary, and who should disclose the incidental information – the ordering physician or the geneticist. Some ethical difficulties associated with professional-related challenges include dilemmas about revealing a colleague’s error, telling the truth about an error made, and blurred, dual or conflicting relationship with patients. In the military, for example, mentalhealthcare professionals sometimes serve as consultants to military commanders as well as providers to individual patients. Occasionally,

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ARTICLE Table 2. General characteristics of studies reviewed Author Agyapong et al.[38] Bahal et al.[48] Bell et al.[45] Beng[44] Chan Smutko et al.[28] Cohen et al.[55] Faith and Chidwick[42] Fine et al.[20] Gupta et al.[60] Hatano et al.[52] Hyde et al.[43] Johnson et al.[14] Kasman[34] Lohiya[37] Mueller et al.[22] Offit et al.[29] Olsen[51] Reynolds et al.[23] Rinehart[56] Schneider et al.[30] Tully et al.[19] Umeorah and Chukwuneke[31] Westra et al.[35] White and Lofwall[57] Youngner[24] Kadooka et al.[26] Ercan Avci[12] Battistuzzi et al.[27] Becker et al.[10] Brown[62] Brown et al.[59] Coggon and Wheeler[54] Daugherty[11] Ganai[15] Gold[58] Gutman[25] Kipnis[39] Lee[21] Lucast[61] Magnavita and Bergamaschi[32] Magnavita et al.[46] McGowan[53] McNamee et al.[16] Miller et al.[49] Monaghan and Begley[50] Lzaro-Muoz[13] Partridge[17] Petrik et al.[47] Purdy and Wadhwani[40] Rentmeester[41] Surbone[33] Turillazzi and Neri[18] Ying[36]

Year 2009 2010 2015 2006 2008 2012 2009 2005 2008 2011 2013 2006 2004 2013 2004 2004 2010 2007 2013 2006 2016 2013 2009 2015 2016 2016 2017 2012 2015 2010 2016 2010 2004 2014 2004 2005 2006 2005 2007 2009 2009 2012 2016 2014 2004 2014 2014 2015 2006 2013 2008 2014 2014

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Type of study Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Case review/analysis Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article Concept/argument-based article

Journal J Forensic Legal Med Int J Surgery Pediatrics Malays Fam Physician Oncologist J Med Ethics Crit Care Nurs Pediatrics J Dev Behav Pediatr J Pain Symptom Manage Dimensions Crit Care Nurs Mil Med J Gen Intern Med J Am Coll Dent Mayo Clin Proc JAMA Am J Nurs Surg Clin N Am Clin Jam Soc Nephrol J Genet Couns AMA J Ethics Ann Med Health Sci Res Eur J Pediatr J Psychiatr Res AMA J Ethics Bioethics Med Health Care Philos Clin Genet J Pain Symptom Manage Pediatr Radiol Clin J Am Soc Nephrol Ann R Coll Surg Engl Cancer Invest World J Surg Intern Med J J Deaf Stud Deaf Educ Am J Bioethics Thorac Surg Clin Bioethics Radiol Med Radiol Med Crit Care Nurs Clin Sports Med World J Surg J Clin Nurs J Law Med Ethics J Bioeth Inq J Psychiatr Pract Neonatal Netw Hum Vaccin Immunother Support Care Cancer BMC Med Ethics World J Surg

ARTICLE these providers are asked to provide reports on patients who are being assessed for promotion; providing such a report may lead to these professionals shifting from a clinical to an evaluative role in relation to these patients.[14-18] Some examples of treatment-planrelated challenges include: difficulties in getting patients and/or their family to appreciate the futility of treatment, and to prepare for death; conflicts between the physician’s expert opinion and family wishes regarding treatment; ethical difficulties with regard to going ahead with an urgent and lifesaving treatment plan when a patient is undecided or cannot make up his/her mind in time to accept a lifesaving organ transplant,[19-24] and conflicts between patient wishes and the physician’s opinion regarding treatment. As these reviewed studies have shown, dealing with an undecided patient can be an ethical nightmare for emergency- and intensive-care unit health professionals, since this often stalls required treatments or leads to communication breakdown.[19] Confidentiality-related challenges generally relate to ethical difficulties with managing information of significant health or personal value; difficulties with regard to keeping patient information private, for example, in a closely knit community such as the Deaf community, where information spreads quickly;[25] and dilemmas regarding the breaching of confidential information in order to benefit third or at-risk parties.[26-31] Finally, regarding challenges arising from differences in values, one frequently occurring issue is the limit of the current medical-ethics framework, specifically principlism, to manage culturally or religiously nuanced clinical contexts, or clinical contexts where physicians and patients are motivated by different religious or cultural values.[32-36]

Fields of practice This review identifies 21 fields of practice within the clinical context, where concept- and argument-based articles and case reviews have examined the challenges described in the preceding section. These fields of practice are: audiology, burn/accident unit, cardiology, dentistry, palliative/oncology, general surgery, genetics, geriatrics, haematology, intensive-care unit, mental healthcare, neonatology, nephrology, nursing, obstetrics/gynaecology, paediatrics, radiology, sports medicine, thoracic, trauma/emergency unit and vaccinology. The reviewed studies reveal that struggling to decide whether to honour a patient’s request not to report abuse is a common ethical conundrum for dentists,[37] mental-healthcare professionals,[38] and paediatricians.[39] In these instances, this dilemma presents a conflict between a professional’s duty to report abuse, and their respect for a patient’s autonomous decision. In regions or countries where protective agencies are inept and overworked and foster care is dangerous or unavailable, reporting child abuse, as Kipnis[39] has pointed out, may be more difficult for a paediatrician, since such a report is more likely to result in termination of therapy and further injury to the child than protection and care. Our review equally shows that neonatal staff also experience dilemmas that they perceive as bordering on child abuse, such as when parents decide to ignore best medical recommendations against initiating aggressive care for an infant with a poor prognosis.[40] In neonatology, conflicts between a physician’s expert opinion and parental or family wishes regarding treatment, leading to communication

breakdown, appear to be a constant source of ethical difficulties for health professionals.[41] Finally, in intensive-care units, some reviewed studies[19,42,43] identified difficulties in getting family members to appreciate the futility of treatment, and going ahead with treatment plans when the patient is ambivalent or indecisive, as two common challenges faced by professionals within this clinical context.

Emotions experienced Studies report that some of the emotions professionals experience when they encounter these ethical challenges are anger, anxiety, frustration, exhaustion, depression, devastation, distress and guilt, to mention but a few, which could lead to burnout.[42,44,45]

Strategies for managing these challenges Four themes for dealing with ethical difficulties regarding information emerged in this review: consultation; negotiating differences; using professional/prudential judgement; and trying to find resolution.

Consultation Consultation is the most widely suggested strategy for managing information and related ethical challenges. This strategy was suggested by the reviewed studies for managing challenges relating to confidentiality, professional duty, value differences, treatment plans and communication-related challenges. Consultation includes seeking the professional advice of colleagues within or outside the field of practice, consulting an ethics committee/group, and consulting with team members. For example, oncologists, intensivists, paediatricians and nurses who face the ethical difficulties of communicating the futility of treatment to patients or family members, or with whom patients or family members have a disagreement over treatment plans, are encouraged to consult with their experienced colleagues within or outside of the hospital. It is believed that these experienced colleagues can provide useful insights for professionals who struggle with the above ethical difficulties.[25,34,47-50]

Negotiating differences Negotiating differences involves engaging in active dialogue with patients and family members to reach common ground when there is a difference of opinion, or holding a discussion with team members with whom there is disagreement over a treatment plan. The negotiation of differences is suggested for resolving disagreements between professionals and patients or family members, such as when parents do not consent to disclosing information to their sick child, or when professionals and patients are motivated by different values. This strategy is also suggested for resolving conflicts between a professional’s opinion and patient or family wishes regarding treatment. For example, when family members cannot agree about whether to withdraw life support, or when family members or proxies hold contrary views regarding the withdrawal of treatment, nurses and intensivists are encouraged to negotiate these differences through active dialogue with the family members or proxies.[33,43,51-56] In addition, when patients cannot make up their minds to consent to urgent lifesaving surgery, White

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ARTICLE and Lofwall[57] found that surgeons find it useful to encourage such patients to discuss their medical options (treatments) with close relatives, since this often leads to situations where patients eventually accept evidence-based treatment(s).

The reviewed studies also show that general surgeons and mentalhealth professionals can seek legal advice or a court order to breach confidential information to benefit at-risk parties.[38,39]

Using professional/prudential judgement

In the previous section, the presentation of our findings was weighted towards some of the 21 fields of practice listed. It is not practically possible to discuss the ethical challenges experienced in each of the 21 fields of practice. We lack the space for such an overwhelming endeavour. The inability to present all the ethical challenges experienced by professionals in each of the 21 fields of practice, as reported by the reviewed studies, is one limitation of this study. This discussion is also not an attempt to discuss the ethical challenges in each of the 21 fields. Notwithstanding, our research question will set the tone of this discussion: ‘How do healthcare professionals manage ethical challenges regarding information within the clinical context?’ Other questions which arise from this research question are: ‘What types of ethical challenges regarding information do concept articles, argument-based articles and case analyses report that clinicians face within the clinical context?’ and ‘How do these clinicians address these ethical issues?’ Therefore, we shall focus on these ethical challenges in general. This review shows that there are five broad types of challenge: communication related, confidentiality related, professional-duty related, value-differences related and treatment plan-related, and four broad strategies (consultation, negotiating differences, using professional/prudential judgement and trying to find resolution) for managing information and related ethical challenges in the 21 fields of practice within the clinical context. New themes and categorisations emerged from this review. Challenges relating to value differences and treatment plans were grouped as subcategories of those relating to decision-making in our review of empirical studies, while negotiating differences and using professional/prudential judgement are entirely new themes that were not present in the review of empirical studies. These new themes and categorisations are the result of our methodological approach – the use of Q-sort techniques that derive themes and codes from texts. In our review of empirical studies,[5] professionals described challenges relating to value differences and treatment plans as ethical dilemmas that often frustrate their decision-making process, and they were categorised as decisionmaking-related challenges in the review of empirical studies. However, in this present review, challenges relating to value differences and treatment plans are discussed – in addition to those related to communication, professional duties and confidentiality – as ethical dilemmas that often lead to communication breakdown amongst professionals or between professionals and patients. This communication breakdown (and how to forestall it) is the theme that underlies all the five broad types of challenges identified in this present review. Information and communication are intrinsically linked. Information is expressed or managed within the context of communication. Therefore, good communication is key to patient care – a breakdown in communication could jeopardise it. It may lead to the provision of information to a patient who is neither ready nor sufficiently prepared to receive such information, resulting in significant distress.

Professional judgement involves the use of discretion to filter (non-) disclosure according to the cultural or religious practices of patients and/or family members, since insensitivity to the patient’s values can lead to the provision of information to someone who is not ready to receive it, causing distress for him/her.[58] This is a commonly suggested strategy for clinical situations where patients and professionals are motivated by different values; it can also be used to manage information when a patient is incapacited. For example, when family members – but not legal proxies – request a patient’s confidential information, and the patient is incapacitated, some studies[42,43] suggest that critical-care nurses and/or mentalhealthcare professionals should carefully judge whether disclosure conforms with prevailing regulations or with the patient’s advance directives (if any). The latter is important especially if the patient, before incapacitation, indicated that he/she did not want his/her family to know anything about his/her medical information. Additionally, in regions where non-disclosure of life-threatening conditions is acceptable, or where patients – owing to cultural or religious influences – consider it a taboo to talk about death, reviewed studies[12,33,59] also suggest that professionals would be ethically correct to filter disclosure according to the cultural beliefs and practices of patients or family, provided that the decision not to disclose information does not in any way jeopardise the treatment of patients or their best interests.[60]

Resolution Finding resolution may involve: deferring decision-making to independent experts when there is a conflict or a blurred/dual relationship with patients; seeking legal advice, waivers or court orders when patients do not consent to providing their health information to parties who may be at risk of infectious diseases or preventable/ manageable health conditions; referring patients to another hospital when differences in a professional’s values and the patient’s cultural beliefs cannot be resolved; and finally, having a discussion prior to diagnosis or treatment to elicit the patient’s wishes. For example, radiologists, nephrologists (within the context of organ transplantation) and geneticists who frequently face the challenge of managing incidental information are encouraged to hold a discussion with the patient at the onset of the clinical relationship to elicit their wishes and preferences regarding (non-)disclosure of such information.[12,61,62] If the patient’s preferences were not elicited before the start of the clinical relationship, and the sociocultural codes of the society indicate that the foreseen (serious) risks are likely to occur, Avci[12] considers that nephrologists who accidentally discover information about misattributed paternity during a human leukocyte antigens (HLA)-typing test are justified in taking a paternalistic decision not to disclose. In addition, military psychologists or psychiatrists who often engage patients in many different contexts and roles (as military colleagues and as patients) are urged to avoid conflicts of duties by referring patients or colleagues to independent experts who might be able to offer appropriate care.[14]

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Discussion

ARTICLE We define communication broadly in this study. It encompasses the content of the communication, the necessary communication skills, and the judgement required to determine when communication is appropriate. In order to prevent significant distress to patients, there is a need to enhance communication between health professionals and their patients, thereby preventing a breakdown of the same within the clinical context. In this regard, this study reaches the same conclusions as those of empirical studies conducted by Lotz et al.,[63] Williams et al.[64] and Helft et al.[65] Some proposals for enhancing communication within the clinical context have been made. Ghazal et al.,[66] for example, proposed the ‘MORAL’ method – massaging dilemmas; outlining options; reviewing criteria and resolving; affirming positions and acting; and finally, looking back. However, recent studies such as that of Brown et al.[59] have concluded that these proposed frameworks and guidelines for enhancing communication within the clinical context have mostly been developed around Anglo-American models of truth-telling and patient autonomy. Many patients and families in certain regions such as Asia and Africa, Brown et al.[59] observe, make decisions using different models that current medical ethics frameworks have not accommodated. New frameworks that adequately accommodate models used by such patients and their families, or that take very seriously the genuine differences that often exist between professionals and patients, will contribute towards bridging this gap. Additionally, we recommend a comprehensive revision of medical-ethics curricula for students to accommodate other models of truth-telling. In the same vein, this study also recommends medical-ethics training and education for health professionals which focuses on a variety of models of communication and truth-telling. In addition to the limitations already stated in this section, this study also has another limitation. We do observe that the tough screening process, as well as the rigorous eligibility criteria and developed search strings, may have resulted in the exclusion of potentially relevant materials. For example, we pooled articles only from studies published between 2004 and 2017; this resulted in the exclusion of potentially relevant articles published before 2004. Notwithstanding the limitations indicated in this section, this review of argumentbased articles and case analyses greatly complements our previous review of empirical studies.[5] This study has increased our knowledge of how healthcare professionals manage ethical challenges regarding information within the clinical context. Future research studies can build on the outcome of this study by developing methods that will enhance communication in a variety of clinical contexts.

Conclusion This review of argument-based articles and case analyses has identified five challenges, related to professional duty, confidentiality, communication, value differences and treatment plans that can act as obstacles to communication within the clinical context. It has also identified four broad (suggested) strategies for addressing these obstacles. They are consultation, negotiating differences, using professional/prudential judgement, and trying to find resolution. Further research is, however, needed to study whether these suggested strategies will indeed enhance communication and fiduciary relations between health professionals and patients. Nonetheless, health professionals should be aware that a number

of strategies exist that they can adopt to address the broad types of challenges identified around information management in a variety of clinical contexts. Acknowledgements. The authors acknowledge and are profoundly grateful to the reviewers and journal editors for their useful, reflective and critical feedback. Author contributions. CE and SH developed the project proposal upon which this study is based. CE and KD adapted a proposal for this particular study and developed the method section of this work. CE was responsible for selecting articles for review, but this was discussed extensively with KD to ensure consistency of inclusion and exclusion criteria. A second revision of the process was done by SH to ensure consistency with the selection criteria, as well as with the larger project aims and objectives. All authors critically revised this manuscript, raised no objections to its submission for publication, and are responsible for its intellectual content. Funding. None. Conflicts of interest. None. 1. Swaminath G. The doctor’s dilemma: Truth telling. Indian J Psychiatry 2008;50(2):83-84. https://doi.org/10.4103/0019-5545.42392 2. Australian Medical Council. Good Medical Practice: A Code of Conduct for Doctors in Australia. Victoria: AMC, 2009. http://www.amc.org.au/joomla-files/ images/Final_Code.pdf (accessed 13 March 2015). 3. Gough IR. The significance of Good Medical Practice: a code of conduct for doctors in Australia. Med J Aust 2014;200(3):148-149. 4. Health Professions Council of South Africa Guidelines for Good Practice in Healthcare Profession. Pretoria: HPCSA. http://www.hpcsa.co.za/Uploads/editor/ UserFiles/downloads/ethical_rules/Booklet%204%20Informed%20Consent%20 September%20%202016.pdf (accessed 12 March 2017). 5. Ewuoso CO, Hall S, Kris, D. How Healthcare Professionals Manage Information and Challenges in the Clinical Context: A Review of Empirical Literature. Stellenbosch: Centre for Applied Ethics, 2017. 6. International Labour Organization. International Standard Classification of Occupations. Geneva: ILO, 2012. http://www.ilo.org/wcmsp5/groups/public/--dgreports/---dcomm/---publ/documents/publication/wcms_172572.pdf (accessed 4 December 2017). 7. Pillastrini P, Vanti C, Curti S, et al. Using PubMed search strings for efficient retrieval of manual therapy research literature. J Manip Physiol Ther 2015:38(2):159-166. http:s//doi.org/10.1016/j.jmpt.2014.11.005 8. Watts S, Stenner P. Doing Q methodology: Theory, method and interpretation. Qual Res Psychol 2005;2(1):67-91. https://doi.org/10.1191/1478088705qp022oa 9. Roberts JK, Hargett CW, Nagler A, et al. Exploring student preferences with a Q-sort: The development of an individualised renal physiology curriculum. Adv Physiol Educ 2015;39(3):149-157. https://doi.org/10.1152/advan.00028.2015 10. Becker G, Jors K, Block S. Discovering the truth beyond the truth. J Pain Symptom Manage 2015;49(3):646-649. https://doi.org/10.1016/j.jpainsymman.2014.10.016 11. Daugherty CK. Examining ethical dilemmas as obstacles to hospice and palliative care for advanced cancer patients. Cancer Invest 2004;22(1):123-131. https://doi. org/10.1081/cnv-120027587 12. Avci E. Should physicians tell the truth without taking social complications into account? A striking case. Med Health Care Philos 2017;7(5):7500. https://doi. org/10.1007/s11019-017-9779-9 13. Lzaro-Muoz G. The fiduciary relationship model for managing clinical genomic incidental findings. J Law Med Ethics 2014;42(4):576-589. https://doi.org/ 10.1111/jlme.12177 14. Johnson WB, Bacho R, Heim M, et al. Multiple-role dilemmas for military mental healthcare providers. Mil Med 2006;171(4):311-315. https://doi.org/10.7205/ milmed.171.4.311 15. Ganai S. Disclosure of surgeon experience. World J Surg 2014;38(7):1622-1625. https://doi.org/10.1007/s00268-014-2558-3 16. McNamee MJ, Partridge B, Anderson L. Concussion ethics and sports medicine. Clin Sports Med 2016;35(2):257-267. https://doi.org/10.1016/j.csm.2015.10.008 17. Partridge B. Dazed and confused: Sports medicine, conflicts of interest, and concussion management. J Bioeth Inq 2014;11(1):65-74. https://doi.org/10.1007/ s11673-013-9491-2 18. Turillazzi E, Neri M. Medical error disclosure: From the therapeutic alliance to risk management: The vision of the new Italian code of medical ethics. BMC Med Ethics 2014;15(1):57. https://doi.org/10.1186/1472-6939-15-57

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ARTICLE 19. Tully AA, Diaz GC, Renz JF. Should physicians attempt to persuade a patient to accept a compromised organ for transplant? AMA J Ethics 2016;18(2):101-107. https://doi.org/10.1001/journalofethics.2016.18.2.ecas1-1602 20. Fine RL, Whitfield JM, Carr BL, et al. Medical futility in the neonatal intensive care unit: Hope for a resolution. Pediatrics 2005;116(5):1219-1222. https://doi. org/10.1542/peds.2004-2790 21. Lee KF. Postoperative futile care: Stopping the train when the family says keep going. Thoracic Surg Clin 2005:15(4):481-491. https://doi.org/10.1016/j. thorsurg.2005.06.005 22. Mueller PS, Hook CC, Fleming KC. Ethical issues in geriatrics: A guide for clinicians. Mayo Clin Proc 2004;79(4):554-562. https://doi.org/10.4065/79.4.554 23. Reynolds S, Cooper AB, McKneally M. Withdrawing life-sustaining treatment: Ethical considerations. Thoracic Surg Clin 2005;15(4):469-480. https://doi. org/10.1016/j.thorsurg.2005.06.002 24. Youngner SJ. How to communicate clearly about brain death and first-person consent to donate. AMA J Ethics 2016;18(2):108-114. https://doi.org/10.1001/jour nalofethics.2016.18.2.ecas2-1602 25. Gutman V. Ethical reasoning and mental health services with deaf clients. J Deaf Stud Deaf Educ 2005;10(2):171-183. https://doi.org/10.1093/deafed/eni017 26. Kadooka Y, Okita T, Asai A. Ethical obligations in the face of dilemmas concerning patient privacy and public interests: The Sasebo schoolgirl murder case. Bioethics 2016;30(7):520-527. https://doi.org/10.1111/bioe.12249 27. Battistuzzi L, Ciliberti R, Forzano F, de Stefano F. Regulating the communication of genetic risk information: The Italian legal approach to questions of confidentiality and disclosure. Clin Genet 2012;82(3):205-209. https://doi.org/10.1111 /j.1399-0004.2012.01935 28. Chan-Smutko G, Patel D, Shannon KM, et al. Professional challenges in cancer genetic testing: Who is the patient? Oncologist 2008;13(3):232-238. https://doi. org/10.1634/theoncologist.2007-0203 29. Offit K, Groeger E, Turner S, et al. The duty to warn a patient’s family members about hereditary disease risks. JAMA 2004;292(12):1469-1473. https://doi. org/10.1001/jama.292.12.146 30. Schneider KA, Chittenden AB, Branda KJ, et al. Ethical issues in cancer genetics: 1) Whose information is it? J Genet Couns 2006;15(6):491-503. https://doi. org/10.1007/s10897-006-9053-4 31. Umeora O, Chukwuneke F. Ethical dilemma and management of infertility in HIV seropositive discordant couples: A case study in Nigeria. Ann Med Health Sci Res 2013;3(1):99-101. https://doi.org/10.4103/2141-9248.109460 32. Magnavita N, Bergamaschi A. Ethical problems in radiology: Radiological consumerism. Radiol Med 2009;114(7):1173-1181. https://doi.org/10.1007/ s11547-009-0438-y 33. Surbone A. Cultural aspects of communication in cancer care. Recent Results Cancer Res 2006;168:91-104. 34. Kasman DL. When is medical treatment futile? A guide for students, residents and physicians. J Gen Intern Med 2004;19(10):1053-1056. https://doi.org/10.1111/ j.1525-1497.2004.40134.x 35. Westra AE, Willems DL, Smit BJ. Communicating with Muslim parents: ‘The four principles’ are not as culturally neutral as suggested. Eur J Pediatr 2009;168(11):1383-1387. https://doi.org/10.1007/s00431-009-0970-8 36. Ying I. Withholding tragic knowledge may lead to a tragic death: A palliative care perspective. World J Surg 2014;38(12):3290-3291. https://doi.org/10.1007/ s00268-014-2676-y 37. Lohiya S. Domestic violence dilemma in the dental clinic. J Am Coll Dent 2013;80(3):9-11. 38. Agyapong VI, Kirrane R, Bangaru R. Medical confidentiality versus disclosure: Ethical and legal dilemmas. J Forensic Leg Med 2009;16(2):93-96. https://doi. org/10.1016/j.jflm.2008.08.007 39. Kipnis K. A defense of unqualified medical confidentiality. Am J Bioeth 2006;6(2):718. https://doi.org/10.1080/15265160500506308 40. Purdy IB, Wadhwani RT. Embracing bioethics in neonatal intensive care, part II: Case histories in neonatal ethics. Neonatal Netw 2006;25(1):43-53. https://doi. org/10.1891/0730-0832.25.1.43 41. Rentmeester CA. Professionalism, fidelity and relationship-preservation: Navigating disagreement and frustration in clinical encounters. Hum Vaccin Immunother 2013;9(8):1812-1814. https://doi.org/10.4161/hv.24432 42. Faith K, Chidwick P. Role of clinical ethicists in making decisions about levels of care in the intensive care unit. Crit Care Nurse 2009;29(2):77-84. https://doi. org/10.4037/ccn2009285 43. Hyde YM, Kautz DD, Jordan M. What to do when the family cannot agree to withdraw life support. Dimens Crit Care Nurs 2013;32(6):276-279. https://doi. org/10.1097/DCC.0000000000000001

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44. Beng KS. Collusion in palliative care. Malays Fam Physician 2006;1(2-3):62-64. 45. Bell SK, Mann KJ, Truog R, et al. Should we tell parents when we’ve made an error? Pediatrics 2015;135(1):159-163. https://doi.org/10.1542/peds.2014-0293 46. Magnavita N, Magnavita G, Fileni A, et al. Ethical problems in radiology: Medical error and disclosure. Radiol Med 2009;114(8):1345-1355. https://doi.org/10.1007/ s11547-009-0445-z 47. Petrik ML, Billera M, Kaplan Y, et al. Balancing patient care and confidentiality: Considerations in obtaining collateral information. Journal Psychiatr Pract 2015;21(3):220-224. https://doi.org/10.1097/PRA.0000000000000072 48. Bahal N, Papanikitas A, Sokol DK. A bleeding controversy: Duties and decisions in the face of conflicting advice. Int J Surg 2010;8(1):32-34. https://doi. org/10.1097/10.1016/j.ijsu.2009.10.002 49. Miller ME, Siegler M, Angelos P. Ethical issues in surgical innovation. World J Surg 2014;38(7):1638-1643. https://doi.org/10.1097/10.1007/s00268-014-2568-1 50. Monaghan C, Begley A. Dementia diagnosis and disclosure: A dilemma in practice. J Clin Nurs 2004;13(3a):22-29. https://doi.org/10.1097/10.1111/j.13652702.2004.00922.x 51. Olsen DP. Want to achieve the ‘greatest good’? Listen to your patients. Am J Nurs 2010;110(2):66-67. https://doi.org/10.1097/01.NAJ.0000368065.85297.2b 52. Hatano Y, Yamada M, Fukui K. Shades of truth: Cultural and psychological factors affecting communication in pediatric palliative care. J Pain Symptom Manage 2011;41(2):491-495. https://doi.org/10.1097/10.1016/j.jpainsymman.2010.12.002 53. McGowan C. Patients’ confidentiality. Crit Care Nurs 2012;32(5):61-64. https://doi. org/10.1097/10.4037/ccn2012135 54. Coggon J, Wheeler R. Confidence and conflicts of duty in surgery. Ann Royal Coll Surg Engl 2010;92(2):113-117. https://doi.org/10.1097/10.1308/00358841 0X12628812458932 55. Cohen LL, Stolerman M, Walsh C, et al. Challenges of genetic testing in adolescents with cardiac arrhythmia syndromes. J Med Ethics 2012;38(3):163-167. https://doi. org/10.1097/10.1136/medethics-2011-100087 56. Rinehart A. Beyond the futility argument: The fair process approach and timelimited trials for managing dialysis conflict. Clin J Am Soc Nephrol 2013;8(11):20002006. https://doi.org/10.1097/10.2215/CJN.12191212 57. White MM, Lofwall MR. Challenges of the capacity evaluation for the consultation-liaison psychiatrist. J Psychiatr Pract 2015;21(2):160-170. https://doi. org/10.1097/01.pra.0000462609.10101.2a 58. Gold M. Is honesty always the best policy? Ethical aspects of truth telling. Intern Med J 2004;34(9-10):578-580. https://doi.org/10.1111/j.1445-5994.2004.00673.x 59. Brown EA, Bekker HL, Davison SN, et al. Supportive care: Communication strategies to improve cultural competence in shared decision-making. Clin J Am Soc Nephrol 2016;11(10):1902-1908. https://doi.org/10.1097/10.2215/CJN.13661215 60. Gupta VB, Willert J, Pian M, et al. When disclosing a serious diagnosis to a minor conflicts with family values. J Dev Behav Pediatr 2008;29(3):231. https://doi. org/10.1097/DBP.0b013e31817996ab 61. Lucast EK. Informed consent and the misattributed paternity problem in genetic counseling. Bioethics 2007;21(1):41-50. https://doi.org/10.1097/10.1111/j.14678519.2007.00522.x 62. Brown SD. The intersection of ethics and communication in prenatal imaging: Challenges for the pediatric radiologist 2010;40(4):514-517. https://doi. org/10.1007/s00247-009-1516-y 63. Lotz JD, Jox RJ, Meurer C, et al. Medical indication regarding life-sustaining treatment for children: Focus groups with clinicians. Palliat Med 2016;30(10):960970. https://doi.org/10.1097/10.1177/0269216316628422 64. Williams C, Alderson P, Farsides B. Dilemmas encountered by health practitioners offering nuchal translucency screening: A qualitative case study. Prenat Diagn 2002;22(3):216-220. https://doi.org/10.1002/pd.289 65. Helft PR, Chamness A, Terry C, et al. Oncology nurses’ attitudes toward prognosis-related communication: A pilot mailed survey of oncology nursing society members. Oncol Nurs Forum 2011;38(4):468-474. https://doi. org/10.1097/10.1188/11.ONF.468-474 66. Ghazal L, Saleem Z, Amlani G. A medical error: To disclose or not to disclose. Clin Res Bioethics 2014:5(2):1-3. https://doi.org/10.1097/doi:10.4172/21559627.1000174

Accepted 2 November 2017.

ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

Public health officials and MECs for health should be held criminally liable for causing the death of cancer patients through their intentional or negligent conduct that results in oncology equipment not working in hospitals D J McQuoid-Mason, BCom, LLB, LLM, PhD Centre for Socio-Legal Studies, Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa Corresponding author: D J McQuoid-Mason (mcquoidm@ukzn.ac.za)

Public health officials and Members of the Executive Council (MECs) for health who allow cancer patients to die because of a failure to renew service contracts for hospital oncology machines – without providing a viable alternative – may be found guilty of having the ‘eventual intention’ to cause such deaths, and convicted of murder if the other elements of the crime are satisfied. Should the National Prosecuting Authority (NPA) decline to prosecute them for murder, they may still be prosecuted for culpable homicide. To succeed in such a prosecution, the NPA would have to prove that reasonable public health officials in their position would have foreseen that a failure to renew service contracts for oncology machines at a hospital might deprive scores of cancer patients of early access to oncology services and result in their deaths. S Afr J Bioethics Law 2017;10(2):83-85. DOI:10.7196/SAJBL.2017.v10i2.611

Consider the following hypothetical scenario: A provincial hospital purchases two state-of-the-art oncology machines that can each treat 100 patients a day. The purchase includes a 5-year service contract to ensure that the machines operate properly. At the end of the 5-year service contract, the Member of the Executive Council (MEC) for Health refuses to renew the contract – despite the fact that no other person or body in the country is qualified to service the machines. The machines run down and are no longer able to service cancer patients at the provincial hospital. Hundreds of cancer patients, who in the past would have been treated with the two hospital oncology machines within 2 weeks of being diagnosed, now have to wait for 9 months for treatment. As a result, their cancer progresses from treatable to terminal, and they die. The hospital’s oncology staff leave because they can no longer treat cancer patients ethically and effectively, as they lack the necessary equipment. The problem is brought to the attention of the MEC and head of the health department on numerous occasions. They do not renew the service contract at ZAR400 000 a month with the authorised service providers to fix the oncology machines so that the hospital can treat 200 patients a day. Instead, the MEC and his colleagues approve a contract with a recently qualified oncology ex-department of health (DoH) employee to treat 50 cancer patients a month at a cost of ZAR2 million a month. The authorised service providers offer to fix the machines for ZAR2.5 million. Despite this offer, the MEC and his colleagues award the ex-employee’s recently formed company with a contract to fix the machines at ZAR5.8 million. In addition, the MEC and his colleagues award the same company a service contract to service the hospital’s two oncology machines at ZAR400 000 a month – even though it does not have the qualifications to do so. The ex-employee is unable to carry out the service contract, and the

oncology machines remain inoperative. Scores of patients continue to die as a result of having to wait months for treatment, by which time their cancer is terminal. Despite public utterances by the MEC and his colleagues to the contrary, and their call to the public to get early treatment for cancer, the machines continue to be inoperative. The above hypothetical scenario begs the question as to whether the MEC for Health, the head of the provincial health department and any other public health officials involved in the cancellation of the service contract for the hospital’s oncology machines – without providing a workable substitute – can be held criminally responsible for the deaths of the cancer patients. It has been suggested that MECs for health, heads of health departments and other responsible public health officials involved in situations similar to those in the above scenario could be held civilly liable for any harm resulting from their conduct.[1] Apart from any criminal liability arising from breaches of the Public Finance Management Act No. 1 of 1999,[2] the question arises whether the MEC and his colleagues in the hypothetical scenario may be held criminally liable for homicide. To answer this, it is necessary to consider if the MEC and public officials may be found guilty of murder, and if not, whether they can be found guilty of culpable homicide.

May the MEC for Health and other public health officials in the hypothetical scenario be found guilty of murder? Murder is the intentional and unlawful killing of another human being.[3] The elements of the murder that have to be proved beyond reasonable doubt in all cases are that: (i) the accused person had the intention to kill; (ii) the person’s act or omission was unlawful;

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ARTICLE (iii) the person caused the death of the other person; and (iv) the other person killed was a human being.[3] The last is usually not in contention – and in the above hypothetical scenario it will be necessary to identify those patients who have died as a result of having their cancer treatment delayed because the oncology machines were not working.

Intention The element of ‘intention’ in murder may take the form of either ‘actual intention’ or ‘eventual intention’. Where a person directs their will to kill a particular person and knows that their act or omission is unlawful, he or she is guilty of ‘actual intention’.[4] Where he or she does not mean to kill a person, but subjectively foresees the possibility that a person may die as a result of their act or omission and continues with such conduct regardless, he or she is guilty of ‘eventual intention’.[4] This happened in the Oscar Pistorius case,[5] where the court held that Pistorius must have subjectively foreseen that if he fired shots into a small bathroom and toilet where somebody was hiding he might kill the person. As a result, he was found to have had the ‘eventual intention’ to kill his girlfriend who was hiding there.[5] The question arises as to whether, in the above hypothetical scenario, the MEC for Health, the head of the provincial DoH and any other public health officials involved in the decision not to renew the oncology-machine service contract with the qualified service provider had the ‘actual’ or ‘eventual intention’ to allow the cancer patients to die. It is self-evident that they did not have the ‘actual intention’ to kill the patients, as this would clearly result in a murder charge. However, did they have the ‘eventual intention’ to do so? Did they subjectively foresee that by not renewing the service contracts, the machines would not function, and up to 200 patients a day in the hospital concerned might be left without treatment – unless alternative arrangements were made? Once they knew that there were no viable alternatives, and that the waiting period for patients in urgent need of oncology treatment had increased from a manageable 2 weeks to a fatal 9 months, there was a legal duty on them to act expeditiously to have the machines repaired. According to the scenario, they were warned, and must have subjectively foreseen, that such a lengthy waiting period would result in the deaths of the patients concerned. Therefore, legally, they had the ‘eventual intention’ to let the patients die.

Unlawfulness Whether or not the conduct of a person accused of murder is unlawful will depend upon the legal convictions of the community,[6] as informed by the provisions of the Bill of Rights in the South African Constitution. [7] The Bill of Rights is clear that everyone should have access to healthcare services (section 27(1)(a)) and that the state must ‘take reasonable legislative and other measures within its available resources to achieve the progressive realisation’ of this right (section 27(2)). Furthermore, children have the right to ‘basic healthcare services’ (section 28(1)(c)) – not merely access to such services. In addition, everyone has the right to life (section 11). Clearly, any breach of these provisions that results in the death of patients is unlawful. The question is whether, in terms of the above hypothetical scenario, the MEC for Health, the head of the provincial DoH and any other public health officials involved in the decision not to renew the oncology-machine service contracts with the qualified service provider

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acted unlawfully. From the scenario, it is clear that the state officials could not argue that they did not have the ‘available resources’ to get the authorised service provider to fix the machines and to enter into service agreements with them. On the contrary, such officials have squandered the provincial DoH’s financial resources by: (i) paying the ex-employee twice as much to fix the machines as the authorised service providers would charge – ZAR5.8 million instead of ZAR2.5 million; and (ii) by paying the ex-employee ZAR2 million a month to treat 50 patients monthly, or 600 patients a year for ZAR24 million. The two hospital oncology machines could have treated 600 patients in 3 months at a cost of ZAR400 000 a month for a total of ZAR1.2 million. Consequently, there is no doubt that legally, the conduct of the state officials mentioned in the scenario was unlawful.

Causation The last question to be answered for criminal liability in a murder charge is whether the conduct of the accused person caused or contributed to the death of the deceased person.[8] In law, the alleged murderer must have both factually and legally have caused or contributed to the death of the deceased. The test for factual causation is whether ‘but for’ the act or omission of the accused person the deceased would not have died.[9] In the hypothetical scenario the question would be: Can it be said that ‘but for’ the failure of the MEC for Health and his colleagues to renew the service contract with the authorised service provider and to keep the two oncology machines operational, scores of patients would not have progressed from treatable cancer to terminal cancer and died? If the answer is in the affirmative – as it must be in the hypothetical scenario – the element of factual causation is satisfied. The next question is whether the MEC for Health, the provincial head of health or other public health officials involved legally caused the death of the deceased. The traditional tests for legal causation were the foreseeability test,[10] the direct-consequence test[11] and the adequate-cause test.[12] The foreseeability test provides that if a person would have reasonably foreseen the likelihood of death resulting from their act or omission and persisted with such conduct, the accused person is regarded as having legally caused the death of the person.[10] The direct-consequence test states that a person is liable for the direct consequences of their act or omission unless some new act intervened between such act or omission and the death of the deceased.[11] According to the adequate-cause test, a person has caused the death of another if such death is ‘adequately connected’ to the act or omission of the accused person.[12] The above three tests are now regarded as ‘subsidiary tests’,[13] and the courts apply a ‘flexible approach’ based on policy considerations such as whether it would be reasonable, fair or just to regard the consequences of a person’s conduct as not being too remote.[13] On this basis, the courts determine ‘whether or not a sufficiently close connection exists between conduct and its consequences’.[13] The ‘subsidiary tests’ may be used to assist the court in making such a determination, but are not in themselves decisive.[13] Whether one applies the three ‘subsidiary tests’ or the flexible test, it seems that in the hypothetical scenario the MEC for Health and his colleagues can be said to have legally caused the deaths of the deceased patients, for the reasons set out below. Under the foreseeability test, a reasonable person in the position of the MEC and his colleagues would have foreseen that early-stage

ARTICLE cancer patients who had to wait 9 months – instead of 2 weeks – for oncology treatment, because the two machines at the hospital were non-operational, might progress from treatable to terminal cancer and die. Similarly, it can be said that the deaths of the patients in these circumstances were a direct consequence of the service contracts not being renewed and no alternative treatment being available. There is also an ‘adequate connection’ between the failure to renew the service contracts and the deaths of the patients from terminal cancer. Finally, under the ‘flexible approach’ it would be reasonable, fair and just to find that there was a ‘sufficiently close connection’ between the omission by the MEC for Health, the provincial head of health or any other public health official to renew the service contracts with an authorised service provider, and the resulting deaths.

May the MEC for Health and other public health officials in the hypothetical scenario be found guilty of culpable homicide? The question arises as to whether if the NPA declines to indict the MEC for Health, provincial head of health or any other public health official for murder, based on their eventual intention to cause the deaths of the cancer patients, such officials may be charged with culpable homicide for negligently causing the deaths of the patients. The crime of culpable homicide consists of negligently and unlawfully causing the death of another person.[14] Except for the requirements of negligence, which are objectively based on conduct – rather than the accused person’s subjective state of mind – the other elements of unlawfulness, causation and the death of a human being are the same, and will not be repeated.

Negligence As mentioned above, negligence deals with a person’s conduct rather than their state of mind. The test for liability in negligence cases is objective, not subjective. According to the common law, a person is negligent if a reasonable person in their position would have foreseen the likelihood of harm and taken steps to prevent it happening.[15] The test for negligence in this case would be: Would a reasonable official in the position of the MEC for Health, provincial head of health or other public health officials involved, have foreseen that by failing to renew the service contracts for the oncology machines at the hospital, such failure might result in the machines not functioning, and that as a result scores of cancer patients would be denied access to oncology services? The answer must be in the affirmative. A reasonable person in the position of the MEC and his colleagues as reflected in the hypothetical scenario would have foreseen that if such patients were compelled to wait for 9 months instead of 2 weeks to receive the

necessary treatment for early-stage cancer – because no alternative services are available – this might result in them progressing from curable to incurable terminal cancer by the time they are scheduled for treatment. There is little doubt that the conduct of the MEC for Health, the provincial head of health or other public health officials referred to in the scenario was negligent, and could result in them being convicted of culpable homicide.

Conclusion Provided the other elements of the crime of murder are present, MECs for health, provincial heads of health or other public health officials who allow cancer patients to die because of a failure to renew service contracts for hospital oncology machines – without providing a viable alternative – may be found guilty of having the ‘eventual intention’ to cause such deaths, and convicted of murder. Where such MECs and their colleagues are not charged with murder, they could still be charged with culpable homicide – if it can be shown that reasonable officials in their position would have foreseen that failure to renew service contracts for the oncology machines at a hospital might deprive scores of cancer patients of access to oncology services and result in their deaths. Acknowledgements. None. Author contributions. Sole author. Funding. None. Conflicts of interest. None.

1. McQuoid-Mason DJ. Public health officials and MECs should be held liable for harm caused to patients through incompetence, indifference, maladministration or negligence regarding the availability of hospital equipment. S Afr Med J 2016;106(7):681-683. https://10.7196/SAMJ.2016.v106i7.10722 2. Public Finance Management Act No. 1 of 1999. 3. Burchell J. Principles of Criminal Law. 3rd ed. Lansdowne. Juta and Co. Ltd 2006:667. 4. Burchell J. Principles of Criminal Law. 3rd ed. Lansdowne. Juta and Co. Ltd 2006:461-463. 5. Director of Public Prosecution Gauteng v Pistorius 2016(1) SACR 431 (SCA) 6. Minister van Polisie v Ewels 1975 (3) SA 590 (A) 7. S v Makwanyane 1995 (3) SA 391 (CC) 8. Burchell J. Principles of Criminal Law. 3rd ed. Lansdowne: Juta and Co. Ltd, 2006:209. 9. S v Daniels 1983 (3) SA 275 (A) 10. Neethling J, Potgieter J, Visser PJ. Law of Delict. 4th ed. Durban: Butterworths, 2001:202-204. 11. S v Goosen 1989 (4) SA 101 (A) 12. Neethling J, Potgieter J, Visser PJ. Law of Delict. 4th ed. Durban: Butterworths, 2001:190-191. 13. S v Mokgethi 1990 (1) SA 32 (A) 14. Burchell J. Principles of Criminal Law. 3rd ed. Lansdowne. Juta and Co. Ltd 2006:159. 15. Kruger v Coetzee 1966 (2) 428 (A)

Accepted 23 October 2017.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

A study of the role and functions of inspectors of anatomy in South Africa P Pillay,1 B Med Sci, H Med Sci, M Med Sci, PhD; D J McQuoid-Mason,2 BComm, LLB, LLM, PhD; K Satyapal,1 LRCP, LRCS, LM, MD, FICA, FRCP, LLM Department of Clinical Anatomy, School of Laboratory Medicine and Medical Sciences, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa 2 Centre for Socio-Legal Studies, Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa 1

Corresponding author: P Pillay (Soobramoneypa@ukzn.ac.za)

Inspectors of anatomy are supposed to monitor and regulate the use of human tissue for teaching and research purposes. In South Africa, provincial inspectors are appointed to oversee this function. However, there is a critical shortage of such persons, and there are only three inspectors currently appointed: one in an acting capacity for KwaZulu-Natal Province, and one each for the Gauteng and Western Cape provinces, respectively. It is imperative, therefore, that the appointment of inspectors of anatomy in the other provinces be addressed urgently. The responsibilities of inspectors of anatomy towards higher-education institutions are to: (i) maintain cadaver records; (ii) ensure that cadavers are obtained in a legal and ethical manner; (iii) carry out inspections of anatomy departments at least once a year; (iv) evaluate health and safety with regard to the storage of specimens; and (v) monitor cadaver procurement. This study recommends the establishment of a National Consultative Anatomy Forum to make decisions on: (i) the type of consent required for donations of bodies; (ii) the mechanisms for the donation of bodies for teaching and research; and (iii) the treatment of unclaimed and/or unidentified bodies. In addition, the forum should advise government on policy, and provide guidelines for the donation and use of cadavers and human tissue. S Afr J Bioethics Law 2017;10(2):86-92. DOI:10.7196/SAJBL.2017.v10i2.619

A review of the legislation and regulations in South Africa (SA) has indicated that provision was made for the statutory appointment of inspectors of anatomy at different stages of SA history. However, there were significant changes between the Human Tissue Act No. 65 of 1983[1] and the National Health Act No. 61 of 2003[2] and its regulations. In SA, provincial inspectors of anatomy are supposed to monitor and regulate institutions dealing with human tissue, as well as the general control of human bodies, tissue and organs for transplantation.[3] However, they are not responsible for issues related to consent, governance and quality control. Therefore, human-tissue regulation by inspectors of anatomy should occur at each of the 11 departments of anatomy at higher-education institutions that are located in five of the provinces. The functions of inspectors of anatomy at higher-education institutions include, inter alia, (i) ensuring that anatomists comply with legislation; (ii) inspecting departments of anatomy; (iii) examining cadaver records, registers or any other document at any time; and (iv) approving the removal and burial of cadavers and tissue from departments of anatomy. A recommendation from the Medico-Legal Symposium held in SA in 2011 was the establishment of national guidelines, with standardised national job descriptions for provincial inspectors of anatomy, and the establishment of an authority similar to the UK Human Tissue Authority[4] to ensure continuity in the treatment of cadavers and tissue throughout the country. As the UK was the first country to appoint inspectors of anatomy under the Anatomy Act of 1832,[5] and since then has moved towards the appointment of the Human Tissue Authority,[4] this study draws comparisons between the UK and SA in this respect.

United Kingdom In the UK, the Anatomy Act of 1832,[5] the Human Tissue Act of 1961[6] and the Anatomy Act of 1984[7] have all provided for inspectors of anatomy, with the fundamental role of regulating human tissue. As a result, the relevant health officials received constant reports from the inspectors, who monitored the use and procurement of cadavers that were used for anatomical teaching.[7] The responsibilities of inspectors of anatomy were: (i) recommending approval of licencing for anatomical examinations; (ii) maintenance of records regarding the bodies donated, their storage and disposal; (iii) inspections and site visits of premises; (iv) ensuring appropriate consent was in place; and (v) making sure that specimens were retained in accordance with legislation.[8,9] Although the legislation set out the specific roles and responsibilities of such inspectors, their individual interpretations varied. On 1 April 2005, the post of inspector of anatomy was subsumed into the new regulatory department known as the Human Tissue Authority (HTA).[4] The HTA was established under the UK Human Tissue Act of 2004,[10] arising from the public furore about the use of human tissue without consent. This regulatory body comprises of a committee of 16 members, who are neither scientists nor medical practitioners.[11] The HTA regulates activities related to anatomical and postmortem examinations, transplantation and retention of human tissue for teaching and research.[12] This is done by creating codes of practice. For example, Code 4 deals with anatomical examination, and Code 5 with the removal, storage, use and disposal of human organs and tissue.[13] The HTA functions in a collaborative and consultative manner by working with medical and scientific groups and conducting public

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ARTICLE consultations. The roles of the HTA were: (i) the inspection and issuing of licences for anatomical and postmortem examinations; (ii) advice to the Secretary of State for Health; and (iii) formulating codes of practice that set out standard operating procedures and guidelines for the use of human tissue.[14] The HTA recognises that consent is a fundamental requirement when using human tissue.

South Africa The Anatomy Act No. 3 of 1911[15] authorised inspectors of anatomy to regulate human tissue. From 1911 to 2002, legislation such as the Prisons Reformatories Prison Act No. 8 of 1959,[16] the Anatomy Act No. 20 of 1959,[17] the Anatomical Donations and Post-mortems Act No. 24 of 1970,[18] the Health Act No. 63 of 1977[19] and the Human Tissue Act No. 65 of 1983[1] all provided for the appointment of inspectors of anatomy to regulate human tissue procurement, storage, use and disposal. The inspectors also had sole power over unclaimed bodies found at public institutions that did not require postmortems. This allowed the inspectors to send such bodies to an authorised school of anatomy for dissection.[20] The responsibilities of inspectors of anatomy were specified as: (i) distribution of bodies that were at their disposal to schools of anatomy; (ii) supervision of burial after 18 months; (iii) maintaining a register of all bodies sent to schools of anatomy; (iv) inspections; and (v) submission of a yearly report to the Minister of Education.[1,17-19] Significant changes occurred with the introduction of the National Health Act No. 61 of 2003,[2] from which the appointment and roles of inspectors of anatomy were omitted, although the act authorises the minister of health to introduce regulations governing the ‘appointment and functions of inspectors of anatomy and investigating officers’. However, this has not yet been done.[21] Although a detailed description of inspectors of anatomy is not included in the act,[2] Chapter 10 establishes an inspectorate of health establishments with health officers appointed for each province.

Regulations In 2011, regulations relating to the control of human bodies, tissue and blood products,[22] and regulations relating to human tissue banks, were promulgated.[23] These regulations stated that the head of a provincial department of health may appoint a provincial inspector of anatomy. The regulations also set out conditions for the appointment and duties of the inspector. However, in 2012, this responsibility was transferred from the head of the provincial department of health to the member of the executive council (MEC) responsible for health, and the latter was authorised to appoint a ‘health officer’ with the same powers and functions as an inspector of anatomy.[23] According to the 2011 regulations regarding the control of human bodies, tissue, blood products and gametes,[22] the stipulated period for an inspector of anatomy to be informed about an unclaimed body was within 30 days of death.[22] The functions of the inspector include, inter alia: (i) ensuring compliance with the regulations; (ii) inspecting premises that have body or tissue products; (iii) examining the records, registers or any other documents at any time; and (iv) removing and burying the remains of a human body or tissue.[22] Although the inspector of anatomy under the 2011 regulations regulated human bodies – and not blood and blood products – for teaching and research, the 2012 regulations describe the powers and functions of the ‘repealed’ inspector of anatomy

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as falling under the ‘inspector of blood transfusion services.’[3] This suggests a need to re-evaluate the clearly defined definitions and role players referred to in the 2012 regulations. According to both sets of regulations, it is an offence if ‘any person refuses or fails to comply to the best of her or his ability with any demand, requirement or order of an inspector of anatomy’ or health officer.[22] As seen from Table 1 below, there has been a change of name from ‘inspector of anatomy’ to ‘health officer’, but the appointment and functions of the health officer remain the same as those of the ‘inspector of anatomy’. Section 68(1) of the National Health Act No. 61 of 2003[2] allows the minister of health to make regulations regarding ‘the appointment and functions of inspectors of the national bloodtransfusion service and progenitor cell-transplant institutions’, as well as the appointment and functions of inspectors of anatomy. The ‘inspector of blood transfusion service’ is referred to in the 2012 regulations, but inspectors of anatomy are not.[24] Although the term ‘inspector of anatomy’ is not referred to in the regulations, a vacancy was advertised for the post of ‘inspector of anatomy’ in 2015.[25] This clearly demonstrates that there is ambiguity in the interpretation of ‘inspectors of anatomy’ and ‘health officers’, and this needs to be urgently amended. This study was undertaken because in SA there are no previously documented studies on the roles, responsibilities, views and challenges of inspectors of anatomy related to the use of human tissue for teaching and research. In addition, the study draws comparisons, recommendations and lessons from the UK, because much of SA’s early legislation on the topic was based on the UK experience, and there are still valuable lessons to be learned from it.

Objectives The aim of this study was to document the role, responsibilities, views and challenges of inspectors of anatomy relating to the use of human tissue for teaching and research in SA. The appointments, qualifications, roles, responsibilities and challenges of the SA inspectors of anatomy were evaluated using semi-structured interviews.

Research design and method The study used semi-structured interviews to obtain qualitative data. Participants were selected using purposive sampling, owing to the limited number of inspectors of anatomy in SA. This resulted in a small sample size, which is characteristic of qualitative research. However, the participants willingly provided valuable information in response to the research question, which contributed to the credibility of the study. Ethical clearance was obtained from the Biomedical Research Ethics Committee of the University of KwaZuluNatal (ref. no. BE 524/14). Semi-structured interviews of 60 minutes each were conducted with the three existing provincial inspectors of anatomy in the Gauteng, KwaZulu-Natal and Western Cape provinces, and with one retired inspector from KwaZulu-Natal. Informed consent was obtained by providing participants with a letter detailing all the processes involved, together with the interview guides. A combination of open- and close-ended questions was used in the interview guide, which enabled the interviewees to elaborate on their answers where necessary. The one-on-one interactions enabled the researcher to ask in-depth questions to answer the research problems, and to explain the questions if further

ARTICLE Table 1. Changes in the definition, appointment of and functions of inspectors of anatomy Legislation Definitions

Method of appointment

Disposal of unclaimed bodies

Notification

Handing over of bodies to institutions

1983 Human Tissue Act No. 65 of 1983[1] ‘Inspector of anatomy’ means an inspector of anatomy appointed as such under section 29(1).

2011 2012 Government Notice R268[3] Government Notice R180[24] ‘Inspector of blood ‘Health officer of blood transfusion services’ transfusion services’ means an inspector of means a health officer of blood transfusion services blood transfusion services appointed as such under appointed by the minister in the Regulations Relating to terms of section 80. Blood and Blood Products.

Comments

An inspector of anatomy does not regulate blood and blood products; however, the health officer of blood transfusion can regulate bodies. The definition in the Human Tissue Act is most suited. A suggestion is the implementation of ‘health officer of anatomy’. Director-General The provincial head of The MEC in each province Change in method of department of health in appointment. The Human each province Tissue Act allowed for the appointment of one or more inspectors, while the NHA allows for one appointment per province. The inspector of anatomy The inspector of anatomy The health officer controls The time period for the body controls the disposal of the controls the disposal of the the body of a deceased to be at the disposal of the body of a destitute person body of a deceased person person that is not buried, inspector has increased from and bodies not claimed or that is not buried, or claimed or claimed for burial within 24 hours to 30 days.The 2012 buried within 24 hours after for burial within 30 days 30 days after the death. The regulations contain a priority the death. The body may be after the death. The body body may be claimed by list of persons who can act as claimed by spouse, relative may be claimed by spouse, spouse, partner, major child, representatives. or bona fide friend. partner, any relative or bona parent, guardian, major fide friend. brother or major sister in the specific order mentioned or bona fide friend. If a body has not been If a body has not been If a body has not been Increase in period of claimed/buried within 24 claimed/buried within claimed/buried within notification from 24 hours to hours after the death, notice 30 days after the death, 30days after the death, a 30 days. is sent to the inspector of notice is sent to the direct notice is sent to the anatomy. inspector of anatomy health officer. concerned. Upon receipt of the notice, Upon receipt of the notice, Upon receipt of the notice, Remains the same. Only an inspector of anatomy an inspector of anatomy the health officer may change is insertion of ‘health may by written order may by written order by written order directly officer’. directly hand the body over directly hand the body over hand the body over to an to an institution. to an institution. institution.

MEC = member of the executive council; NHA = National Health Act.

information was required.[26] The interviews were recorded in handwriting and on audiotape to ensure the accuracy of the data-capturing. The information was then transcribed by an independent transcriber. The qualitative data were analysed by ‘converting raw data into partially processed data’.[26] The data were analysed iteratively by moving backwards and forwards between data collection and analysis. Data were collected and analysed on an ongoing basis, enabling the researcher to identify themes.[27] The themes were extracted through observation (seeing), coding (recognising something in it) and interpretation, and subsequently analysed.[28] The data were validated by asking two of the interviewees to verify the themes generated, and to comment on the accuracy of the interpretation and conclusions drawn by the researcher.[26] The

scientific rigour of the data was established by using peer review, in which an external reviewer also read and critiqued the data and interpretations. The themes that emerged from the data included: (i) the method of appointment of inspectors of anatomy; (ii) their functions; (iii) ethical issues they faced; (iv) the challenges they faced; and (v) recommendations they made. For the purpose of this study, the inspectors of anatomy are referred to anonymously by numbers (i.e. inspectors 1, 2, 3 and 4.).

The method of appointment of inspectors of anatomy The study showed that there were three male inspectors of anatomy and one female appointed in SA between 1994 and 2015. Prior to 2006,

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ARTICLE the posts were managed by the SA Police Services (SAPS). Since 2006, however, inspectors of anatomy have fallen under the management of the provincial departments of health forensic pathology services. The qualifications of the inspectors of anatomy varied, and at different stages have included: (i) a specialist pathologist; (ii) a dental practitioner with an honours degree in reproductive biology; (iii) a chief forensic pathologist; and (iv) a nursing education/occupational health practitioner. The method of appointment as inspector of anatomy differed across the provinces. Inspectors 1 and 2 commented that they ‘incidentally landed in the post’ owing to specific interests in medical ethics, and were appointed by ‘default’. Inspector 2 specified that ‘as an occupational health practitioner, you are at the forefront if you are an inspector of anatomy’. Inspector 1 indicated that in 2006, the provincial department of health assumed responsibility for the medicolegal services from SAPS. This resulted in the appointment of the provincial forensic pathologist in the additional role of inspector of anatomy. Inspector 3 stated that the post for the inspector of anatomy was advertised with a requirement of ‘problem-solving’ as a skill, as well as a background in the health sector. Inspector 4 stated that for his/her appointment, the nominations were made by the provincial department of health, since the post was a statutory appointment. Their levels of experience as inspectors of anatomy ranged from 5 years to 15 years.

Functions of inspectors of anatomy The forensic services department in the provincial departments of health manage the post of inspector of anatomy. In one province, the inspector is also the chief forensic pathologist. The daily functions of inspectors of anatomy include co-ordinating the maintenance of the forensic services’ mortuaries and performing investigations into unnatural deaths. The interviewees stated that their responsibilities towards higher education institutions are: (i) the maintenance of cadaver records; (ii) ensuring that cadavers are obtained in a legal and ethical manner; (iii) carrying out inspections of anatomy departments at least once a year; (iv) evaluating health and safety regarding the storage of specimens; and (v) monitoring cadaver procurement. Inspector 2 believed that his/her role was ‘to ensure that [he] provide cadavers to departments of anatomy for learning purposes’, while Inspector 1 declared that his/her role has ‘changed since the advent of the National Health Act, whereas under the Human Tissue Act their [duties were] quite specific regarding the monitoring of the whole of anatomy’. Inspector 3 is the only inspector of anatomy without a dual function, and this individual’s priority is human-tissue regulation. His/her daily functions include: (i) dealing with exhumations; (ii) authorising the import and export of human remains; (iii) ensuring appropriate ethical conduct when research related to cadaveric or living tissue is performed at a hospital or higher-education institution; (iv) monitoring donations of human tissue; (v) advising hospital personnel on dealing with unclaimed or unidentified bodies; (vi) carrying out inspections of hospitals, biobanks, mortuaries, or any place that holds human tissue; (vii) investigating complaints related to the use of human tissue; and (viii) developing policies related to human tissue.

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The inspectors recognised that the current legislation, the National Health Act, is not as comprehensive regarding the functions of an inspector of anatomy as the repealed Human Tissue Act, because the latter was much more precise in this regard. The 2012 regulations of the National Health Act introduced the term ‘health officer’,[24] but did not define the term adequately. To date, no new regulations describing the appointment and function of inspectors of anatomy have been promulgated. Inspector 1 noted the following: ‘In reading the terms and conditions of the functions in the National Health Act, the act itself does not talk to the regulations, so we don’t know where we stand in terms of regulations. There is reference to a ‘health officer’ but no clear-cut definition of what a health officer is. Traditionally, an inspector used to be a medical practitioner.’ Inspector 4 suggested that the National Health Act should define and incorporate the role of inspectors of anatomy into the legislation. It was further stated that the current inspectors ‘need to be aware of all the regulations’. Inspector 2 believed that the National Health Act ‘build-up is perfect regarding process and procedure for donation’. However, the inspector stated that the legislation was inadequate on many issues: (i) the act does not allow the use of human tissue within 24 hours of death for the training of surgical specialities; (ii) the time period allocated to the identification of unclaimed bodies is too short; and (iii) the management of the identification process needs to be addressed. According to the National Health Act, the introduction of the Office of Health Standards does not include a specific reference to inspectors of anatomy. Instead it refers to inspectors related to health-systems management. In the words of Inspector 2: ‘This leaves the inspector of anatomy virtually on their own, and means at the provincial level you need a person that understands the crisis and can drive the agenda at national level.’ Inspector 3 stated that the National Health Act regulations extended the work of the environmental health officers ‘without the actual competence’. Inspector 1 stated that repatriation of human tissue is overseen by the environmental-health officer, which poses a challenge to the inspector of anatomy, since all human tissue may not be adequately monitored. Since the appointment of inspectors of anatomy is a statutory position, an inspector is expected to submit annual year-end reports to the MEC responsible for health. In addition, the inspectors must ensure compliance with the law at hospitals and higher-education institutions in their designated provinces. According to Inspector 4, prior to the passing of the National Health Act, unclaimed and unidentified bodies were the property of the state, and managed by the relevant inspector of anatomy. Instead of a pauper burial, these bodies were donated by the inspectors of anatomy to departments of anatomy. Unclaimed indigent bodies (i.e. bodies of the poor and families experiencing financial constraints) are often not claimed either by the family or a friend of the deceased. The families of unclaimed bodies of indigent persons are encouraged to donate such bodies to departments of anatomy in the provinces concerned. The departments of anatomy cover the costs of the transportation and disposal of the bodies once the academic year is completed. Once the inspector of anatomy approves the donation, the bodies are sent to a designated department of anatomy.

ARTICLE Ethical issues faced by inspectors of anatomy Inspector 1 suggested that the practice of sending an unclaimed and unidentified pauper body to a department of anatomy is ‘most problematic as it results in ethical dilemmas’. The ethical dilemma arises because consent is not possible in these cases. Inspector 1 stated that their role was that of a ‘custodian of ethics and law’. In contrast, another inspector posed the rhetorical question: ‘Whose ethics? Is it my ethics or your ethics or our personal beliefs?’ This inspector mentioned that by ‘treating the body with respect and dignity, you are working within an ethical framework’. Inspector 1 further stated that: ‘[if ] pauper burials are the solution to all unclaimed and unidentified bodies at hospitals and mortuaries, then where is the dignity and respect if you have five bodies buried together in an unmarked common grave? The exhumation process for the purpose of identification does not afford dignity to all the bodies in that particular pauper grave. Inspector 1 believes that the humane way of dealing with an unclaimed and unidentified body is to send the body to a department of anatomy, to be embalmed and stored for a period of time, with processes in place to identify the body. Inspector 2 suggested that in the event of a pauper burial, there should be an awareness of the cultural background of the deceased. In addition, there should be a proper method of identifying an unclaimed and unidentified body. Moreover, those who cannot afford the burial should be encouraged to donate the body to a department of anatomy. Inspector 2 indicated that there was a need for discussions with the public, media, anatomists and legal representatives on a way forward. In this regard, Inspector 3 stated: ‘Human tissue of the unclaimed can be used as long as the body is treated with dignity and the body can be claimed at any time. If it is incorrect to use pauper bodies due to ethical reasons, then whose ethics? Ethics changes from person to person. If it is unethical, what is the solution? I make sure the regulations are known to hospitals. Therefore, hospital personnel inform me, the inspector of anatomy, if there is an unclaimed or unidentified body. The family of the unclaimed body is given the choice of either having a pauper burial or donating their body to an anatomy department.’

Challenges faced by inspectors of anatomy Some of the challenges experienced by the inspectors of anatomy are: (i) the management of tissue at higher-education institutions; (ii) the issue of the legality of departments of anatomy in provinces with no inspector; (iii) the dual functions of inspectors; (iv) provincial inspectors working in silos; (v) the failure to define the post of inspector of anatomy in the National Health Act; (vi) the fact that some hospitals are not ‘pro-donation’ in certain provinces; (vii) the absence of standard operating procedures or guidelines for all provinces; and (viii) the failure to have all human tissue monitored by one authority.

Recommendations made by the inspectors of anatomy The inspectors of anatomy made the following recommendations: • An inspector of anatomy appointee should be someone with a medical or surgical background.

• In order for the appointee to function optimally, there should be no dual functioning of an inspector. • Heads of departments of anatomy should be held accountable for human tissue that is used for teaching and research, and required to monitor the cadaver records and understand the law. • There need to be benchmarks of the functions of inspectors of anatomy, and guidelines and uniform standard operating procedures promulgated. • If the inspector of anatomy’s interpretation of the law differs from those of others, the inspector should consult the stipulated regulations, as they provide guidance for the necessary adherence. • An inspector of anatomy should be appointed in every province where there is a department of anatomy, biobank or any other institution dealing with human tissue.

Discussion A review of the legislation and regulations in SA indicated that there has been provision for the appointment of inspectors of anatomy at different stages of SA history. At present, the implementation of the use of or procurement of cadavers, in terms of the National Health Act and its regulations, falls under the jurisdiction of the inspector of anatomy in the respective provinces. The National Health Act regulations state that approval for the use of unclaimed indigent bodies must be authorised by a written order from an inspector.[24] However, the notice period for this to occur may be short. Furthermore, the regulations relating to the management of human remains[29] state that unclaimed bodies are to be disposed of according to the regulations regarding the rendering of the forensic pathology service.[30] These state that the body of an unclaimed and unidentified person must be stored in a freezer within 7 days of death, and that if the body remains unidentified for 30 days, the local municipality must provide a pauper burial or cremation for the body.[31] The regulations relating to the general control of human bodies, tissue and organs for transplantation, however, state that the body of a deceased person that is not buried, or claimed for burial within 30 days, is at the disposal of the health officer in whose area the body is located.[24] A review of the roles and responsibilities of inspectors of anatomy in the UK, compared with their role in SA revealed that in the UK, their posts have been incorporated into the HTA. Table 2 shows the comparison between the HTA and the inspector of anatomy and/or health officer in SA. The HTA deals with: (i) consent; (ii) the donation of bodies for anatomical examination; (iii) guidance and standard operating procedures for persons working in anatomy; (iv) licensing; and (v) the inspection of the use of bodies and tissue in research and education by medical organisations.[12-14] Furthermore, the HTA authorises the storage and anatomical examination of bodies, provided that this is carried out by or under the direction of a ‘designated individual’. In SA, inspectors of anatomy regulate the general control of human bodies, tissue and organs for transplantation, and do not stipulate the standards related to consent, governance and quality control. The interviews with the inspectors of anatomy revealed that there were two inspectors of anatomy fully appointed, and one in an acting capacity, in only three of the nine provinces of SA. In the provinces with no inspectors of anatomy, their role may be carried out by the forensic pathology services. The background, experience

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ARTICLE Table 2. Summary of UK Human Tissue Authority v. SA inspector of anatomy Legislation Relevant section Method of appointment Background/expertise Framework Scope of the post

Responsibility

Establishment of standards

Human Tissue Authority (UK) Human Tissue Act of 2004[10] Code 4: Anatomical Examination Regulatory body with 16 lay persons Non-medical and non-scientist

Inspector of anatomy (SA)/health officer National Health Act No. 61 of 2003[2] Regulations Provincial inspector of anatomy/health officer Medical person or with medical-related background with some knowledge of law and medical ethics Provide advice and guidance Regulation of human tissue Code 4 allows the donation of whole bodies for anatomical Regulations regarding the general control of human examination (with consent) and for the storage and bodies, tissue and organs for transplantation anatomical examination of a body; provides guidance and standard operating procedures for persons working in anatomy The remit includes the removal, storage and use of human Variable in provinces: according to legislation, inspectors bodies, import and export of human bodies and the of anatomy must (i) ensure compliance with the disposal of human tissue; inspecting and issuing licences regulations; (ii) inspect premises that have body or tissue to establishments; preparation of codes of practice setting products; (iii) examine the records, registers or any other out standards; providing advice to the Secretary of State documents at any time; and (iv) remove and bury the for Health and the public remains of human bodies or tissue Consent is the overriding principle for activities involving Not clearly established in regulations, as those relating to the use of human tissue; tissue taken should be treated inspectors of anatomy have not yet been promulgated with respect and the dignity of the person be maintained at all times; the standards are consent, governance and quality systems, premises, facilities and equipment, and disposal of bodies or tissue

and responsibilities of the inspectors of anatomy vary across the different provinces. Although inspectors of anatomy are present in some provinces, there are higher-education institutions in SA that are facing critical cadaver shortages owing to ethical constraints. In two provinces, the inspectors of anatomy play an integral role in assisting departments of anatomy to procure cadaveric material. It was suggested at a medicolegal symposium held in SA in 2011 that national guidelines should be established, with a standardised national job description, for provincial inspectors of anatomy. The suggestion was also made that police officers should be deputised as human-tissue inspectors where there were no inspectors of anatomy.[32] However, the recommendations from the inspectors of anatomy interviewed in the study are that persons with a medical qualification, knowledge of ethics and the law and the ability to solve problems would be ideal candidates for appointment. One of the other problems highlighted during the interviews was the issue of the dual functions of inspectors, and the need for this to be addressed. In order to achieve this, however, the roles and responsibilities of inspectors of anatomy need to be clearly defined in the regulations that in terms of the National Health Act should be promulgated by the minister of health.[23] According to the National Department of Health, the main function of an inspector of anatomy is ‘to ensure compliance in regards to handling, donation, transportation, use, disposal, import and export of human tissue’.[33] The inspectors interviewed during the study all emphasised the need to delineate their functions, because their job descriptions often differed from their daily tasks. Owing to varying ethical perceptions by the inspectors regarding the use of bodies and tissue for anatomical teaching and research, there is a need for clear regulations to be promulgated.

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Conclusion and recommendations The roles and functions of the inspectors of anatomy in their respective provinces differed from their daily tasks. Some of the challenges experienced by the inspectors of anatomy were: (i) the management of tissue at higher-education institutions; (ii) the dual functions of inspectors of anatomy; (iii) provincial inspectors working in silos; (iv) the failure to define the post of inspector of anatomy in the National Health Act; (v) hospitals not being ‘pro-donation’ in certain provinces; (vi) the absence of a standard operating procedure or guidelines for all provinces; and (vii) the failure to have all human tissue monitored by one authority. The study demonstrated that inspectors of anatomy play a major role in the regulation of human tissue in SA. Therefore, it is imperative that the appointment of inspectors of anatomy in all provinces be addressed urgently. The National Health Act allows the minister of health to make regulations related to the appointment and functions of inspectors of anatomy; however, these have not yet been promulgated. Clarity regarding the nomenclature used is required. In addition, the formation of provincial and national guidelines, together with standard operating procedures, should be introduced by the provincial health authorities. The study showed that inspectors of anatomy play a major role in the regulation of human tissue in SA. Therefore, it is imperative that the issue of the appointment of inspectors of anatomy in all provinces be addressed urgently. In addition, clarity with regard to the nomenclature used is required. Provincial health authorities should introduce provincial and national guidelines, together with standard operating procedures, for anatomists. Given the concerns of the inspectors of anatomy interviewed, and what the study has shown regarding the operation of the UK HTA, it is submitted that

ARTICLE a national consultative anatomy forum should be established to make decisions on: (i) issues of consent; (ii) the donation of bodies for teaching and research; and (iii) the use of unclaimed and/or unidentified bodies. Such a forum could also advise the minister of health on questions of policy, the promulgation of the necessary regulations and the need for standard operating procedures. The forum would operate as an overarching body that incorporates key role players, including the inspectors of anatomy, together with representation from anatomists, academics, legal advisors and other relevant stakeholders. It is necessary that such a forum would be fully inclusive of the belief systems of the diverse SA population, as well as being aimed at improving the quality of anatomical teaching and research in the country. Acknowledgements. The authors would like to thank the inspectors of anatomy for their participation and contributions to this article through their interviews. Author contributions. PP contributed to the design and implementation of the research, to the analysis of the results and to the writing of the manuscript. DMM and KS provided critical feedback and helped shape the research, analysis and manuscript. Funding. None. Conflicts of interest. None. 1. South Africa. Human Tissue Act No. 65 of 1983. 2. South Africa. National Health Act No. 61 of 2003. 3. South Africa. National Health Act of 2003. Regulations regarding the control of human bodies, tissue, blood products and gametes. Government Gazette No. 34159, 2011. (Published under Government Notice R268). https://www.gov.za/sites/www. gov.za/files/334159_gon268.pdf (accessed 4 July 2016). 4. Human Tissue Authority. HTA Codes of Practice and Standards. London: HTA, July 2006. https://www.hta.gov.uk/guidance-professionals/codes-practice (accessed 15 January 2016). 5. United Kingdom. Anatomy Act of 1832. 6. United Kingdom. Human Tissue Act of 1961. 7. United Kingdom. Anatomy Act of 1984. 8. Riederer BM, Bolt SH, Brenner E, et al. The legal and ethical framework governing body donation in Europe – 1st update on current practice. Eur J Anat 2012;16(1):1-21. 9. MacDonald H. The anatomy inspector and the government corpse. Hist Aus 2010;6(2):40-41. https://doi.org/10.2104/ha090040 10. United Kingdom. Human Tissue Act of 2004. 11. McHale J. The Human Tissue Act 2004: Innovative legislation – fundamentally flawed or missed opportunity? Liverp Law Rev 2005;26(2):169. https://doi.org/10.1007/ s10991-005-4842-7 12. Human Tissue Authority. HTA Code of Practice 4 – Anatomical Examination. London: HTA, July 2006. https://www.hta.gov.uk/guidance-professionals/codes-practice (accessed 15 January 2016).

13. Human Tissue Authority. HTA Code of Practice 5 – Disposal of human tissue. London: HTA, 2016. https://www.hta.gov.uk/sites/default/files/Code_of_practice_5_-_ Disposal_of_human_tissue.pdf (accessed 15 January 2016). 14. Human Tissue Authority. HTA Codes and Standards. https://www.hta.gov.uk/ sites/default/files/Code%20C%20-%20Anatomy%20Final_0.pdf (accessed 15 January 2017). 15. South Africa. Anatomy Act No. 3 of 1911. 16. South Africa. Prisons Act No. 8 of 1959. Section 35. Prisons and Reformatories. 17. South Africa. Anatomy Act No. 20 of 1959. Section 6(1)(a). 18. South Africa. Anatomical Donations and Post-mortems Act No. 24 of 1970. 19. South Africa. Health Act No. 63 of 1977. Section 48(2). 20. South Africa. Human Tissue Act No. 65 of 1983. Section 29(1). 21. South Africa. National Health Act No. 61 of 2003. Section 68(1)(m). 22. South Africa. National Health Act of 2003. Regulations regarding the control of human bodies, tissue, blood products and gametes. Government Gazette No. 34159, 2011. (Published under Government Notice R268). https://www.gov.za/sites/www. gov.za/files/334159_gon268.pdf (accessed 4 July 2016). 23. South Africa. National Health Act of 2003. Regulation 5 of the Regulations regarding human tissue banks. Government Gazette No. 34159, 2011. (Published under Government Notice R267). https://www.greengazette.co.za/documents/regulationgazette-34159-of-01-apr-2011-vol-550-no-9511_20110401-GGR-34159 (accessed 4 July 2016). 24. South Africa. National Health Act of 2003. Regulation 20(1) of the Regulations regarding human tissue banks. Government Gazette No. 35099, 2012. (Published under Government Notice R180). http://www.saflii.org/za/legis/consol_reg/ nha61o2003rangnr180590.pdf (accessed 4 July 2016). 25. National Department of Health, South Africa. SA Government Vacancy: Inspector of Anatomy. http://sa-government-vacancies.blogspot.com/2015/04/vacancyinspector-of-anatomy.html (accessed 27 July 2017). 26. Teddlie C, Tashakkori A. Foundations of Mixed Methods Research: Integrating Quantitative and Qualitative Approaches in the Social and Behavioural Sciences. Thousand Oaks, CA: Sage, 2009. 27. Patton MQ. Qualitative Evaluation and Research Methods (3rd ed.). Thousand Oaks, CA: Sage, 2002. 28. Eisner EW. The Enlightened Eye: Qualitative Inquiry and the Enhancement of Educational Practice. Upper Saddle, NJ: Merrill, 1998. 29. South Africa. National Health Act of 2003. Regulations relating to management of human remains. Government Gazette No. 30075, 2007. (Published under Government Notice R636). www.saflii.org/za/legis/consol_reg/nha61o2003rangnr363590.pdf (accessed 4 July 2016). 30. South Africa. National Health Act of 2003. Regulations regarding the rendering of the forensic pathology service. Government Gazette No. 30075, 2007. (Published under Government Notice R636). www.saflii.org/za/legis/consol_reg/ nha61o2003rangnr636590.pdf (accessed 4 June 2016). 31. South Africa. National Health Act of 2003. Regulation 32 of the Regulations regarding the rendering of the forensic pathology service. Government Gazette No. 30075, 2007. (Published under Government Notice R636). www.saflii.org/za/legis/consol_ reg/nha61o2003rangnr636590.pdf (accessed 4 June 2016). 32. McQuoid-Mason D. UKZN anniversary symposium on the medicolegal and ethical implications of human tissue use. S Afr J Bioethics Law 2011;294(1):13-44. 33. Department of Health, Provincial Government of Western Cape, South Africa. Forensic Pathology Services Newsletter. Up Close and Personal: Ryan Clayton – Inspector of Anatomy. Cape Town: Provincial DoH, Western Cape: June/July 2011:2. https://www.westerncape.gov.za/Other/2011/12/fps_newsletter_3.pdf (accessed 2 June 2016).

Accepted 17 October 2017.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

The 2016 CIOMS guidelines and public-health research ethics J R Williams, PhD School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ontario, Canada Corresponding author: J R Williams (jrewms@yahoo.com)

In November 2016, the Council for International Organizations of Medical Sciences (CIOMS) published its revised International Ethical Guidelines for Health-related Research Involving Humans. In relation to earlier versions, the scope of the new guidelines has been expanded to include public-health research. While successful to some extent, the document does not take into sufficient account the differences between public-health research and other types of health research. It is silent on some issues of importance to public-health research, such as its definition, health inequities and novel research methodologies. Its treatment of some other issues, including the need for researchethics committee approval, consent, community involvement and dissemination of research results, are deficient in some respects. The guidelines that are particularly applicable to and useful for public-health research deal with social value, the health needs of communities and populations, community engagement, disasters and disease outbreaks, cluster randomised trials and data sharing. Much further development of the foundations and applications of public-health research ethics is needed to inform future revisions of the guidelines and of other international and national research-ethics documents. S Afr J Bioethics Law 2017;10(2):93-95. DOI:10.7196/SAJBL.2017.v10i2.605

On 29 November 2016, the executive of the Council for International Organizations of Medical Science (CIOMS) approved the newly revised version of International Ethical Guidelines for Health-related Research Involving Humans.[1] This document combines and replaces the 2002 CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects and the 2009 ClOMS International Guidelines for Ethical Review of Epidemiological Studies. It was produced by an expert working group that met numerous times between September 2012 and June 2016. Public-health researchers have often complained that both international research-ethics guidelines such as the Declaration of Helsinki and the CIOMS documents, and most, if not all, national guidelines and regulations, do not take sufficient account of the differences between public-health research and other health-related research.[2] The primary aim of these documents is the protection of individual research participants and, to a lesser extent, communities, whereas public-health research prioritises health promotion and disease prevention among populations over protection of individuals.[3] When reviewed by research-ethics committees (RECs), public-health protocols are often judged by the same standards and criteria as clinical trials, even when these are clearly inappropriate. Do the 2016 CIOMS guidelines deal adequately with the ethical aspects of public-health research? In what follows I argue that although they are partially successful in this regard, they are silent on some important public-health research issues, and problematic on others.

Ethical issues on which the guidelines are especially useful In some respects the 2016 document represents a significant advance over previous versions, and contains much useful information for

public-health researchers. The following guidelines are particularly applicable to public-health research: • Guideline 1, ‘Scientific and social value and respect for rights’, states that ‘all research is [to be] carried out in ways that uphold human rights, and respect, protect and are fair to study participants and the communities in which the research is conducted.’ There was no guideline on social value in previous versions, and the commentary on this guideline makes explicit mention of public health in relation to social value. • The new guideline 7, ‘Community engagement’, does not mention public health as such, but is clearly applicable. The commentary provides a broad definition of ‘community’ that ‘consists not only of people living in the geographical area where research is to be carried out; it also comprises different sectors of society that have a stake in the proposed research, as well as subpopulations from which research participants will be recruited’. However, the guideline and commentary do not include community approval of or consent to research as an aspect of engagement, and they leave important questions unasked (see below). • The new guideline 20, ‘Research in disasters and disease outbreaks’, is clearly relevant to public-health research. It reflects the great amount of ethical analysis of responses to recent pandemics of severe acute respiratory syndrome (SARS), avian influenza and Ebola[4,5] and, to a lesser extent, of earthquakes and weather-related disasters, although there is no mention of wars. • Another new guideline, 21, ‘Cluster randomised trials’, is likewise of major concern to public-health research, since those randomised are ‘groups of individuals (clusters), communities, hospitals, or units of a health facility’. However, the guideline’s primary focus, as throughout the entire document, is on individual members of these groups, whether patients or healthcare workers.

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ARTICLE • Guideline 24, ‘Public accountability for health-related research’, calls on researchers to share their data, thereby echoing previous demands from those engaged in public-health research.[6]

Ethical issues on which the guidelines are silent What public-health research is

Whereas medical research has well-established methodologies, such as clinical trials, that differentiate it from medical practice, it is sometimes difficult to determine whether a public-health activity is research or something else, such as programme evaluation or quality improvement, and the guidelines do not address this issue.

Health inequities Although the first guideline is entitled ‘Scientific and social value and respect for rights’, neither the guideline nor its commentary mentions health inequities, a major concern of public health.[7]

Novel research methodologies The guidelines do not mention the evaluation of research methodologies that are unfamiliar to members of RECs, such as those employed by some public-health researchers.[8,9] The commentary on guideline 23 requires RECs to ‘either carry out a proper scientific review, verify that a competent expert body has determined the research to be scientifically sound, or consult with competent experts to ensure that the research design and methods are appropriate’. However, the guideline provides no criteria for making such a judgement.

Ethical issues on which the guidelines are problematic To what extent are the guidelines applicable to public-health research?

On the one hand, the preface states that ‘the current scope is confined to the classic activities that fall under health-related research with humans, such as observational research, clinical trials, biobanking and epidemiological studies.’ Although this list may not be intended to be exhaustive, it is unclear whether all public-health research is included within ‘classic activities’. Just below, however, the preamble claims that ‘the ethical principles set forth in these guidelines should be upheld in the ethical review of research protocols. The ethical principles are regarded as universal.’ (Unlike the 2002 version of the guidelines, this one does not name its ethical principles, nor is there any definition or discussion of ethics.) This statement, and others found throughout the document, suggest that all health-related research activities, including public-health research, are subject to the same principles and procedures for ethics review.

When is REC approval required? Guidelines 10 and 23, which deal with this matter, are at best unclear and arguably inconsistent, especially with regard to public-health research. No. 23 states: ‘All proposals to conduct health-related research involving humans must be submitted to a REC to determine whether they qualify for ethical review and to assess their ethical acceptability, unless they qualify for an exemption from ethical review (which may depend upon the nature of the research and upon applicable law or regulations)’. The commentary on this guideline

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includes the following paragraph on exemptions from review: ‘Some studies may be exempt from review. For example, when publicly available data are analysed or the data for the study are generated by observation of public behaviour, and data that could identify individual persons or groups are anonymized or coded, the study may be exempt. Health-systems research may be exempted from review if public officials are interviewed in their official capacity on issues in the public domain’. It is unclear whether the researcher has the authority to decide if a study qualifies for exemption from REC review or whether this is the prerogative of the REC. A similar problem is found in guideline 10, ‘Modifications and waivers of informed consent’, which states unequivocally: ‘Researchers must not initiate research involving humans without obtaining each participant’s individual informed consent or that of a legally authorised representative, unless researchers have obtained explicit approval to do so from a research ethics committee’. However, the commentary on this guideline states: ‘When a study is performed under a public-health mandate or by public-health authorities, such as disease surveillance, normally neither ethical review nor a waiver of consent is needed because the activity is mandated by law’. The commentary compounds this ambiguity where it says: ‘Although the extent and limits of data collection are determined by law, researchers must still consider whether, in a given case, it is ethical to use their authority to access personal data for research purposes’. No criteria are given for making this determination.

Consent The primary focus of public-health research is human populations and the institutions that provide healthcare, rather than individual research participants. Populations include ethnic groups, residents of a specific geographical location, an identifiable group either affected by or susceptible to some health condition, a virtual community sharing a common interest and connected on the internet, etc. The guidelines do mention research on populations, but their main concern is individual research participants, as is evident in their numerous entries on consent. Throughout the document ‘consent’ applies only to individuals. In guideline 7 on ‘Community engagement’, there is no mention of community consent for research, although the co-operation of the community is usually very important, if not essential, for research to proceed. Moreover, RECs need to decide whether researchers have to give the community an opportunity to consent to the dissemination of the results of the research as a condition for their agreement to participate in a study. Three new guidelines deal with problematic aspects of consent that arise in public-health research. The very lengthy guideline 20, ‘Research in disasters and disease outbreaks’, requires that ‘the individual informed consent of participants is obtained even in a situation of duress, unless the conditions for a waiver of informed consent are met’. The last of these conditions from guideline 10 – that the research would not be feasible or practicable to carry out without the waiver or modification, the research has important social value, and the research poses no more than minimal risks to the participants – may be impossible to fulfil in disasters and epidemics. When there are entire populations affected by an earthquake or outbreak of infectious disease, different interventions can be implemented, and evaluated afterwards to determine which were more effective

ARTICLE in alleviating the health effects of the disaster. It would often be impossible to obtain individual consent from all those involved in the interventions.[10] Guideline 21, ‘Cluster randomised trials’, is more permissive in allowing exceptions to individual informed consent. The guideline authorises researchers, sponsors, relevant authorities and RECs to ‘determine whether it is required or feasible to obtain informed consent from patients, healthcare workers, or community members in certain studies’ and to ‘determine whether requiring informed consent and allowing refusal to consent may invalidate or compromise the research results’. However, the commentary on the guideline withdraws this discretion from researchers, and stipulates that for such research, a waiver or modification of consent must be obtained from a REC. Guideline 22, ‘Use of data obtained from the online environment and digital tools in health-related research’, deals mostly with privacy. Where it does mention consent it reverts to what seems to be a requirement for individual consent to use online personal healthrelated data: ‘Researchers should inform persons whose data may be used in the context of research in the online environment of: the purpose and context of intended uses of data and information; the privacy and security measures used to protect their data, and any related privacy risks; and the limitations of the measures used and the privacy risks that may remain despite the safeguards put in place’. Although this statement uses ‘should’ rather than ‘must’, it is arguably too restrictive. Much public-health data, including official statistical reports, can be obtained from conventional media sources such as newspapers and the internet. Even though the data may identify individuals or communities, there should generally be no need to obtain their consent. Whether this applies to data from so-called social media (Facebook, Twitter, etc.) is unanswered in the guidelines.

Community involvement Although the new guideline 7 deals explicitly with this topic, it leaves several questions unasked. How can researchers, especially those from outside, gain the trust of the population, especially if the population has had negative experiences with previous researchers? If the researchers, or their assistants, are from within the population, how can they avoid a conflict of interest between the requirements of the research and the needs or desires of population members? Who owns the results – the researchers or the population, or both? Does the population have a right to participate in the interpretation of the data? Can it veto the dissemination of results that could stigmatise it? A REC needs to be assured that the researchers have considered these issues and have a sound plan to deal with them before the project is approved.

Dissemination of research results Guideline 24, ‘Public accountability for health-related research’, requires researchers to ‘prospectively register their studies, publish the results and share the data on which these results are based in a timely manner’. The commentary on this guideline states: ‘Researchers and sponsors have an obligation to register their studies before they actually start’. As desirable as this may be, it is not feasible for most public-health research. There is no public-health research equivalent

of the various clinical-trial registries where proposed studies can be listed and, in some cases, their results can be summarised.

Conclusion Public-health researchers can be pleased that CIOMS has recognised that the ethics of research applies to their field just as much as to other types of health-related research. They will likely be concerned, however, that the differences between their needs and those of other health researchers are not sufficiently accounted for in the revised guidelines. This is understandable, considering the relative underdevelopment of public-health research ethics compared with other health-research ethics, which benefits from a huge literature and multiple international and national guidelines and regulations. One can hope that the new CIOMS guidelines will spur all those involved in public-health research ethics to intensify their efforts to develop both the theoretical foundations and the practical applications of this field, so that the next revision of the guidelines, and of other international and national research ethics documents, will be as useful for public-health research as for all other health research. Acknowledgements. None. Author contributions. Sole author. Funding. None. Conflicts of interest. JRW has written a module on public-health research ethics for the TRREE (Training and Resources in Research Ethics Evaluation) e-learning programme (http://elearning.trree.org/), for which he received no remuneration. Some excerpts from the module have been incorporated in this article. 1. Council for International Organizations of Medical Science. International Ethical Guidelines for Health-related Research Involving Humans, 4th ed. Geneva: CIOMS, 2016. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMSEthicalGuidelines.pdf (accessed 18 July 2017). 2. Verweij M, Dawson A. Public health research ethics: A research agenda. Public Health Eth 2009;2(1):1-6. https://doi.org/10.1093/phe/php008 3. Bayer R. Mass testing and mass treatment for epidemic HIV: The ethics of medical research is no guide. Public Health Eth 2010;3(3):301-302. https://doi. org/10.1093/phe/phq022 4. Presidential Commission for the Study of Bioethical Issues. Ethics and Ebola: Public Health Planning and Response. Washington DC: Presidential Commission, 2015. http://bioethics.gov/sites/default/files/Ethics-and-Ebola_PCSBI_508.pdf (accessed 18 July 2017). 5. World Health Organization. Guidance for Managing Ethical Issues in Infectious Disease Outbreaks. Geneva: WHO, 2016. http://apps.who.int/iris/bitstre am/10665/250580/1/9789241549837-eng.pdf (accessed 18 July 2017). 6. Langat P, Pisartchik D, Silva D, et al. Is there a duty to share? Ethics of sharing research data in the context of public health emergencies. Public Health Eth 2011;4(1):4-11. https://doi.org/10.1093/phe/phr005 7. Horn L. Public health and social justice: Forging the links. S Afr J Bioethics Law 2015;8(2):26-29. https://doi.org/10.7196/SAJBL.437 8. Teti M, Murray C, Johnson L, Binson, D. Photovoice as a community-based participatory research method among women living with HIV/AIDS: Ethical opportunities and challenges. J Emp Res Hum Res Ethics 2012;7(4): 34-43. https:// doi.org/10.1525/jer.2012.7.4.34 9. Womack CA. Looking beyond labeling: From calories to construction of new menus and venues for healthier eating. Public Health Eth 2015;8(1):103-105. https://doi.org/10.1093/phe/phv001 10. Adebamowo C, Bah-Sow O, Binka F, et al. Randomised controlled trials for Ebola: Practical and ethical issues. Lancet 2014;384(9952):1423-1424. https://doi. org/10.1016/S0140-6736(14)61734-7

Accepted 17 October 2017.

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ARTICLE

This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

End-of-life practices: The opinions of undergraduate medical students at a South African university C Marais,1 3rd-year medical student; J Smouse,1 3rd-year medical student; G Poortier,1 3rd-year medical student; A Fair,1 3rd -year medical student; G Joubert,2 BA, MSc; W J Steinberg,3 MB BCh, DTM and H, DPH, Dipl Obst (SA), MFamMed, FCFP (SA) School of Medicine, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa Department of Biostatistics, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa 3 Department of Family Medicine, Faculty of Health Sciences, University of the Free State, Bloemfontein, South Africa 1 2

Corresponding author: W J Steinberg (SteinbergWJ@ufs.ac.za)

Background. Modern people live increasingly longer lives owing to advances in medicine and medical technology. This has raised many ethical questions regarding the prolongation of life, the right to die and euthanasia. Objective. To determine the opinions of medical students at the University of the Free State (UFS), South Africa (SA), regarding end-of-life practices: terminal pain management, withholding/withdrawing potentially life-sustaining treatment, advance directives and assisted dying. Methods. This was an observational, cross-sectional quantitative study. A self-administered and anonymous questionnaire was distributed to undergraduate medical students (preclinical and clinical). Demographic data were collected. Results. The overall response rate was 71.6% (481/672; preclinical 82.4% and clinical 64.4%). Students agreed that patients should have access to medical care (90.0%), and that pain medication should be state-supplied (86.3%). Students agreed that patients should have the right to refuse medical care (72.1%) and/or potentially life-preserving treatments (69.8%). Overall, 67.3% of students agreed that doctors should have the right to turn off life support if requested in the patient’s living will. Students (78.4%) disagreed that life support may be turned off without consent. Clinical students (54.5%) supported assisted dying being legal in SA, compared with the preclinical students (31.4%). While 43.0% of students agreed that assisted dying should be legal, only 36.2% were willing to perform the procedure themselves. Conclusion. Medical students at UFS agree with the legislation of three of the end-of-life practices: terminal pain management, withholding/ withdrawing potentially life-sustaining treatment and advance directives. The clinical students, however, are more in favour than preclinical students of assisted dying becoming legal. S Afr J Bioethics Law 2017;10(2):96-101. DOI:10.7196/SAJBL.2017.v10i2.604

Modern people live increasingly longer lives owing to advances in medicine and the application of medical technology, but this has raised many ethical questions regarding the prolongation of life, the right to die and euthanasia.[1,2] In South Africa (SA), it is illegal to terminate a person’s life or assist therein in order to end pain and suffering, even for a terminally ill patient. The common law criminalises euthanasia, but allows a patient to instruct a doctor to withhold/withdraw potentially life-sustaining treatment.[1] According to the SA Law Commission, terminal illness refers to an illness, injury or other physical or mental condition that, in medical judgment, will inevitably cause the patient’s death and is producing extreme suffering, or will cause an irreversible vegetative condition.[1] In 2011, the Ethics Institute of SA (EthicsSA)[3] conducted a scoping survey among doctors and specialists at two medical schools in SA, in which more than 80% of participating doctors indicated that assisted dying should only be contemplated when a patient is terminally ill, while 12% believed that assisted dying does not require a terminal illness. End-of-life decisions are categorised into the following four practices by the legal fraternity: (i) terminal pain management; (ii) withholding or withdrawing of potentially life-sustaining treatment; (iii) advance directives; and (iv) assisted dying. Patients in SA have the right to affordable palliative care in the case of a terminal illness.[4]

Under the National Patients’ Rights Charter, published by the Health Professions Council of SA (HPCSA),[4-6] patients have the right to refuse treatment. The National Health Act No. 61 of 2003[6] allows patients, in writing, to designate a person to act on their behalf when they are no longer capable of doing so themselves. ‘Assisted dying’ is an umbrella term that entails all end-of-life interventions in the dying process.[3] ‘Assisted suicide’ means that a person intentionally provides the means for a competent person to take their own life. ‘Voluntary active euthanasia’ means that a competent person at the end of life asks another person to perform an act which is the proximate cause of death. In this article, the term ‘assisted dying’ will be used in a narrower sense to refer to both assisted suicide and voluntary active euthanasia. While studies have concentrated on what qualified doctors think about end-of-life decisions, it is of interest to ascertain the opinions of medical students (‘doctors in training’). A study was conducted among medical students at a university in Croatia about their opinion on euthanasia, before and after bioethics education on the topic.[7] Before the course, their attitudes toward euthanasia largely varied with respect to religion and according to whether they were rural or urban. After the training, students were significantly more positive towards euthanasia, and no differences between subgroups were

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ARTICLE found. A study by Weber et al.[8] among German final-year medical students revealed limited confidence and knowledge concerning palliative-care issues. A study in the Netherlands highlighted the need to pay more attention to education on end-of-life care in the medical curriculum.[9]

Objective This study aimed to determine the opinions of medical students at the University of the Free State (UFS), Bloemfontein, SA, regarding end-of-life practices.

Methods

Study design and population This was an observational, cross-sectional quantitative study, conducted between July and November 2016. The study population was all the registered first- to fifth-year medical students at the School of Medicine, UFS: 672 students in total. The undergraduate MB ChB curriculum presented by UFS spans 5 academic years. During the second part of their studies, students gain clinical experience in teaching hospitals and clinics. For this study, firstand second-year students are referred to as the preclinical group. Thirdyear students had started with their first clinical semester at the time of the study, and are referred to, together with the fourth- and fifth-year students, as the clinical group. At the beginning of the third year, as part of an ethics module, students have four sessions on palliative care.

Measurement The measurement tool, designed by the researchers, was a selfadministered and anonymous questionnaire adapted from the survey used by Landman,[3] and was available in English only. Demographic data were collected. Students’ opinions on the four end-of-life practices were determined by formulated questions or statements. Each question or statement had five options, of which participants had to mark one: strongly agree, agree, neutral, disagree and strongly disagree. Of the 12 questions, two questions focused on terminal pain management, withholding or withdrawing potentially life-sustaining treatment and advance directives. Six questions focused on the practice of assisted dying. Questionnaires were handed out by the student researchers to the preclinical and third-year students during lectures, and collected after immediate completion. The clinical students completed their questionnaires in their respective rotation groups.

Pilot study A pilot study was done on a convenient sample of 10 second-year occupational therapy students of the Faculty of Health Sciences, UFS, to enhance the validity of the questionnaire. Minor spelling changes were made to the questionnaire, and an additional question allowing the students to comment was added.

Analysis of the data Data were analysed by the Department of Biostatistics, Faculty of Health Sciences, UFS. Categorical information was summarised by frequencies and percentages, and numerical variables by means, standard deviations or percentiles. For reporting of results, the categories ‘strongly agree’ and ‘agree’ were grouped together, as were the categories ‘disagree’ and ‘strongly disagree’.

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Ethical considerations The protocol was approved by the Health Sciences Ethics Committee, UFS (ref. no. HSREC-S-45/2016). Permission was obtained from the Vice Rector: Research, Dean of the Faculty of Health Sciences and head of the School of Medicine, UFS. Participation was voluntary. Completing and handing in the questionnaire was considered to constitute consent to the study.

Results The overall response rate was 71.6% (481/672). The response rate for each medical year group is indicated in Table 1. Almost all of the participants (96.8%) were in the age range 17 - 25 years, and 41.3% were male and 58.7% female.

Terminal pain management The majority of students (90.0%) agreed that all people should be granted full medical care (Table 2). The fifth-year group had the lowest percentage agreeing (79.0%), and the highest percentage disagreeing (8.1%). Most students (86.3%) agreed that patients should have access to state-supplied pain medication during endof-life care. The first-year group had the lowest percentage agreeing (77.0%) and the highest percentage choosing the neutral option (17.6%).

Withholding potentially life-sustaining treatment Most of the students (72.1%) agreed that a patient should have the right to refuse medical care, while 69.8% agreed that patients should be allowed to refuse potentially life-preserving treatment (Table 3). A fifth (20.3%) of the first-year students felt that patients should not have this right, compared with 9.7% of fifth-year students. First-year students were also the group with the highest percentage (26.4%) disagreeing that patients should be allowed to refuse treatment.

Advance directives Only 54.4% of first-year students agreed that they would turn off life support if this was requested in the patient’s living will, compared with 79.0% of fifth-year students (Table 4). The majority of students (78.4%) were of the opinion that a doctor should not be allowed to turn off life support without the consent of the family or the patient. More preclinical students were opposed to this practice than clinical students. However, at least 20% of fourth- and fifth-year students were neutral on this practice, compared with less than 10% each in the remaining groups.

Assisted dying Across all five groups, only 36.2% would assist a patient in carrying out Table 1. The response rates of undergraduate medical students in their respective year groups Preclinical 1st year 2nd year Clinical 3rd year 4th year 5th year

Students in year, N

Participants, n (%)

178 109

148 (83.1) 89 (81.7)

140 123 122

90 (64.3) 92 (74.8) 62 (50.8)

ARTICLE Table 2. The opinions of undergraduate medical students regarding pain management as an end-of-life practice (%)

All All people, irrespective of age or health status, should be granted full medical care Strongly agree Agree Neutral Disagree Strongly disagree Patients should have state-supplied access to pain medication during end-of-life care Strongly agree Agree Neutral Disagree Strongly disagree

65.0 25.0 6.9 2.1 1.0 51.8 34.5 8.9 2.5 2.3

Preclinical 1st 2nd year year

3rd year

Clinical 4th year

94.6

92.1

86.5

91.3

79.0

5.4

4.5

7.9

6.5

12.9

3.4

5.6

2.2

8.1

77.0

85.4

93.3

91.3

91.9

17.6

7.9

3.3

5.4

3.2

5.4

6.7

3.3

4.8

5th year

Table 3. The opinions of undergraduate medical students regarding withholding potentially life-sustaining treatment as an endof-life practice (%)

All The patient should not have the right to deny medical care* Strongly agree Agree Neutral Disagree Strongly disagree Patients should be allowed to deny potentially life-preserving treatment* Strongly agree Agree Neutral Disagree Strongly disagree

4.8 9.4 13.7 37.2 34.9 26.3 43.5 12.5 11.9 5.8

Preclinical 1st 2nd year year

3rd year

Clinical 4th 5th year year

20.3

14.6

12.2

8.7

9.7

19.6

12.4

12.2

5.4

16.1

60.1

73.0

75.6

85.9

74.2

58.8

68.5

75.3

83.7

69.4

14.9

14.6

13.5

5.4

12.9

26.4

16.9

11.2

10.9

17.7

*Phrasing as on questionnaire, in text referred to as â&#x20AC;&#x2DC;refuseâ&#x20AC;&#x2122;.

Table 4. The opinions of undergraduate medical students regarding advance directives as an end-of-life practice (%) Preclinical 1st 2nd year year

3rd year

Clinical 4th 5th year year

All A doctor should have the right to turn off life support provided it is in the living will of the patient Strongly agree 24.0 54.4 65.2 78.9 70.7 79.0 Agree 43.3 Neutral 16.9 17.7 15.7 13.3 22.8 12.9 Disagree 8.5 27.9 19.1 7.8 6.5 8.1 Strongly disagree 7.3 A doctor should have the right to turn off life support, with evidence of life not being sustainable, without the consent of family or the patient Strongly agree 2.1 6.9 6.7 13.8 10.0 13.8 Agree 7.5 Neutral 12.0 8.3 6.7 9.2 18.9 22.4 Disagree 32.5 84.7 86.5 77.0 71.1 63.8 Strongly disagree 45.9

a procedure linked to assisted dying, while 45.3% would not assist and 18.5% were neutral (Table 5). Half (53.8%) of the preclinical students would not assist a patient in carrying out a procedure linked to assisted dying. The clinical group was slightly more in favour of the idea, with at

least 40% willing to carry out the procedure. A higher percentage of this group, however, remained neutral compared with the preclinical group. Clinical students were more inclined to opt for assisted dying if they were ever terminally ill themselves (54.9%), while only 31.0%

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ARTICLE Table 5. The opinions of undergraduate medical students regarding assisted dying as an end-of-life practice (%) Preclinical Clinical 1st 2nd 3rd 4th 5th All year year year year year Would you as a medical professional assist a patient in carrying out a procedure linked to assisted dying, provided it was legal to do so? Strongly agree 11.9 32.4 25.8 41.1 43.5 41.9 Agree 24.3 Neutral 18.5 12.8 21.4 17.8 23.9 21.0 Disagree 17.9 54.7 52.8 41.1 32.6 37.1 Strongly disagree 27.4 If ever in the position of being terminally ill, would you perhaps opt for assisted dying, provided it was legal? Strongly agree 16.2 30.4 31.5 55.6 57.6 51.6 Agree 27.0 Neutral 20.2 21.6 24.7 13.3 17.4 24.2 Disagree 15.2 48.0 43.8 31.1 25.0 24.2 Strongly disagree 21.4 Would you, as a medical professional, carry out a euthanising procedure, provided it was legal? Strongly agree 11.3 22.9 23.6 35.6 38.9 36.2 Agree 18.8 Neutral 20.1 20.8 11.2 18.4 28.9 20.7 Disagree 15.4 56.3 65.2 46.0 32.2 43.1 Strongly disagree 34.4 A committee consisting of medical professionals and lawyers should determine whether a patient is eligible for an assisted-dying procedure Strongly agree 15.8 31.8 46.1 35.6 52.2 50.0 Agree 25.6 Neutral 17.7 13.5 12.4 25.6 20.7 19.4 Disagree 23.1 54.7 41.6 38.9 27.2 30.7 Strongly disagree 17.9 The decision on whether the assisted-dying procedure may be carried out should be legally decided upon by the patient and doctor alone Strongly agree 11.9 40.5 45.5 51.1 28.3 24.2 Agree 27.1 Neutral 20.6 16.9 14.8 18.9 28.3 29.0 Disagree 23.8 42.6 39.8 30.0 43.5 46.8 Strongly disagree 16.7 Assisted dying should remain illegal in South Africa Strongly agree 15.7 42.9 30.3 24.4 19.6 24.6 Agree 14.6 Neutral 26.7 25.9 38.2 22.2 26.1 19.7 Disagree 26.7 31.3 31.5 53.3 54.4 55.7 Strongly disagree 16.3

of preclinical students agreed, and 23.2% remained neutral. In the clinical group, the percentage of students remaining neutral increased from 13.3% in the third years to 24.2% in the fifth years. Except for the fourth-year students, the highest percentage in each group would not carry out a euthanising procedure, even if it was legal. Just over 60% of preclinical students would not carry out this procedure, compared with 44.6% of third- and fifth-year students. Overall, secondyear students had the highest percentage of disagree responses (65.2%). Even though the highest percentage of fourth-year students (38.9%) agreed that they would carry out a euthanising procedure, they were also the group with the highest percentage of neutral responses (28.9%). Medical students were almost equally divided between agreeing (41.4%) and disagreeing (41.0%) that a committee consisting of medical professionals and lawyers should determine whether a patient is eligible for an assisted-dying procedure. First-year students mostly disagreed (54.7%), while half of fourth- and fifth-year students agreed. There was no definite trend between the preclinical and

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clinical groups; second, fourth and fifth years were more inclined to agree, while first and third-years tended to disagree. The students were also almost equally divided (39.0% agree; 40.5% disagree) on whether or not the decision to carry out an assisted dying procedure should be legally regulated upon by the patient and doctor alone. No definite trend was apparent. The highest percentage in secondand third-years agreed, while first, fourth and fifth years disagreed. While 43.0% of students disagreed that the practice of assisted dying should remain illegal in SA, more than a quarter (26.7%) were neutral. First-year students tended to agree with this statement (42.9%), whereas more than 50% of clinical students disagreed.

Discussion Results from this study show that undergraduate medical students at UFS agree that terminally-ill patients should receive terminal pain management and have access to pain medication during end-of-life care. This is in line with the HPCSAâ&#x20AC;&#x2122;s National Patientsâ&#x20AC;&#x2122; Rights Charter.[4]

ARTICLE There was a strong leniency towards the patient having the right to refuse medical care and potentially life-preserving treatment, which is in line with current legislation.[1] The clinical group was more in agreement with this practice than the preclinical group, showing that students in their clinical years are more accommodating of patient autonomy. The clinical students clearly supported the practice of allowing patients to make decisions regarding their life and health. Most of the students would turn off life support if this was specified in a living will; however, a percentage of students indicated that they would not turn off life support even when consent was given in a living will. The majority of students were clear on the issue that life support should not be turned off unless prior permission or discussion had occurred with the family or patient. In the EthicsSA survey, 75% of responding doctors agreed that advance directives help to clarify a patient’s wishes regarding treatment when incompetent and at the end of life, whereas only 12% disagreed.[3] Differing opinions were seen between the preclinical and clinical groups regarding the practice of assisted dying. The role of clinical exposure and responsibility affecting the view of assisted dying needs to be further investigated. The question on whether students would opt for assisted dying should they themselves be terminally ill showed that it seems a more realistic possibility for the clinical students, after exposure to terminal cases. There was a 20.0% difference between the preclinical and clinical groups for this scenario, with clinical students more in favour of opting for assisted dying if they were the patient. When the question was directed at their professional opinion as to whether they are willing to carry out an assisted dying procedure, the difference dropped to under 10%. This may be the result of clinical students realising that their professional and personal opinions overlap. They need to accept that, if they would ever want the procedure carried out on themselves, they may be obliged to perform an assisted dying procedure. A slightly higher percentage of medical students (30.1%) would be willing to carry out a euthanising procedure than the 25% of respondents in the EthicsSA study,[3] affirming that they would administer a lethal drug, if requested, provided euthanasia was legal. Our results also showed that 36.2% of the students would help a patient to carry out an assisteddying procedure, compared with 30.1% who would carry out voluntary active euthanasia. Although the difference is only 6.1%, the results may indicate that medical students make a moral distinction between assisted dying and euthanasia. First-year students showed more support for the doctor and patient to make an end-of-life decision rather than a multiprofessional committee consisting of medical professionals and lawyers. However, the more experienced clinical students (fourth and fifth years) showed more support for allowing a committee to make the decision rather than the doctor and patient alone. These two year-groups also had the highest neutral percentages of 28.3% and 29.0%, respectively, on whether they think the doctor and patient should have sole responsibility in end-of-life decisions. The clinical students therefore seem to better appreciate the support of the multi-professional committee, or to want to delegate the responsibility to someone else. Current laws in SA do not allow either assisted dying or the carrying out of euthanising procedures. In 2016, SA’s laws were challenged on this matter by the Stransham-Ford v the State case, where the

Supreme Court of Appeals denied the prosecutor the right to have the procedure carried out on Robert Stransham-Ford, overturning the ruling of SA’s High Court made in 2015.[10] The question as to whether assisted dying should remain illegal in SA is central to this study. Overall, 43.0% of students felt that assisted dying should be legalised, while 26.7% remained neutral. However, just over 30% of preclinical students supported legalising assisted dying, compared with more than 50% of clinical students. According to the EthicsSA survey, 38% of physicians indicated that doctor-assisted suicide should be legalised. When further asked if voluntary active euthanasia should be legalised, 34% strongly agreed or agreed.[3] Even though 43.0% of the students agreed that assisted dying should be legalised in SA, only 36.2% would be willing to be involved. This result shows that clinical students at UFS have similar views to practising doctors in Bloemfontein on this issue.[3] A similar study on attitudes towards euthanasia and physician-assisted suicide in Switzerland showed significant variations among medical students, oncology clinicians and palliative-care specialists.[11] It does seem that, in general, fewer doctors than students are in favour of assisted dying. However, another study in 2009 that aimed to find out the opinions of doctors in the private sector in Bloemfontein indicated that 82.3% of the doctors would never perform an assisted-dying procedure.[12] It is not clear whether this may indicate a change in views over time, or a lack of standardised measuring tools used by the different studies.

Study limitations During the study, fifth-year students were busy with their final examinations. The poor response rate among the fifth-year students may have resulted in biased results. The measuring tool was adapted to create scenarios more understandable to medical students, rather than medical practitioners. Students were not given much time to deliberate and prepare, nor to discuss answers to the questions. Furthermore, this study only reports on the opinion of the current medical students of one medical institution in the country.

Conclusion and recommendations From the results, medical students at UFS agree with the legislation of three of the end-of-life practices: terminal pain management, withholding or withdrawing potentially life-sustaining treatment and advance directives. The clinical students, however, are more in favour than the preclinical of assisted dying becoming legal. The topic of assisted dying should be integrated into the curriculum, making available adequate background information and implications for practice, so that a well-informed decision can be made. The authors recommend further studies to obtain opinions from other medical schools in SA. Acknowledgements. The authors thank Dr L van der Merwe, Undergraduate Medical Programme Director, School of Medicine, UFS, for her assistance with the logistical arrangements, and Ms T Mulder, medical editor, School of Medicine, UFS, for technical and editorial preparation of the manuscript. The students’ voluntary participation in the study is appreciated. Author contributions. CM, JS, GP and AF developed the protocol, performed the data collection and did the initial write-up of this

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ARTICLE study. GJ assisted with the planning, performed the data analysis and assisted with the interpretation and write-up of this study. WJS was the supervisor of this study, suggested the concept, assisted with the protocol development, data collection and interpretation of data, and was responsible for the write-up of this study. Funding. None. Conflicts of interest. The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in the writing of this article. 1. South African Law Commission. Euthanasia and the Artificial Preservation of Life. Project 86. Pretoria: SA Law Commission, 1998. 2. Chidoori REP. Should passive euthanasia be made legal in South Africa? Doctoral dissertation. East London: University of Fort Hare, 2009. 3. Landman WA. End-of-life decisions, ethics and the law: A case for statutory legal clarity and reform in South Africa. Geneva: Globethics.net, 2012. http:// www.globethics.net/documents/4289936/13403252/FocusSeries_09_ EndOfLifeDecision_Willem_text.pdf/e4c50a25-5c89-465b-b341-e7a957d5a1da (accessed 7 December 2015). 4. Health Professions Council of South Africa. National Patients’ Rights Charter. Booklet 3. Pretoria: HPCSA, 2008. 5. Health Professions Council of South Africa. Guidelines for the Withholding and Withdrawing of treatment. Booklet 12. Pretoria: HPCSA, 2008.

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6. South Africa. National Health Act No. 61 of 2003. 7. Sorta-Bilajac I, Brkanac D, Brozović B, et al. Influence of the ‘Rijeka model’ of bioethics education on attitudes of medical students towards death and dying – a cross-sectional study. Coll Antropol 2007;31(4):1151-1157. 8. Weber M, Schmiedel S, Nauck F, Alt-Epping B. Knowledge and attitude of finalyear medical students in Germany towards palliative care – an interinstitutional questionnaire-based study. BMC Palliat Care 2011;10(19):1-7. https://doi. org/10.1186/1472-684X-10-19 9. Hesselink BA, Pasman HR, van der Wal G, Soethout MB, Onwuteaka-Philipsen BD. Education on end-of-life care in the medical curriculum: Students’ opinions and knowledge. J Palliat Med 2010;13(4):381-387. https://doi.org/10.1089/ jpm.2009.0291 10. Stransham-Ford v the Minister of Justice and Correctional Services and Others 2015 (4) SA 50 (GP). http://www.saflii.org/za/cases/ZASCA/2016/197.pdf (accessed 10 May 2017). 11. Marini MC, Neuenschwander H, Stiefel F. Attitudes toward euthanasia and physician assisted suicide: A survey among medical students, oncology clinicians, and palliative care specialists. Palliat Support Care 2006;4(3):251-255. https://doi. org/10.1017/S1478951506060329 12. Brits L, Human L, Pieterse L, Sonnekus P, Joubert G. Opinions of private medical practitioners in Bloemfontein, South Africa, regarding euthanasia of terminally ill patients. J Med Ethics 2009;35(3):180-182. https://doi.org/10.1136/ jme.2008.027417

Accepted 17 October 2017.

CPD QUESTIONNAIRE

December 2017 True (A) or false (B): The Life Esidimeni tragedy: Constitutional oath betrayed 1. Members of Provincial Executive Councils in South Africa take an Oath of Allegiance to the Constitution when sworn into office. Life Esidimeni psychiatric patients in Gauteng Province, South Africa: Clinicians’ voices and activism – an ongoing, but submerged narrative 2. People with mental illness are seen in low regard because of stigma. 3. A court interdict to prevent patients from being moved out of Life Esidimeni in March 2016 was dismissed. 4. The Gauteng Department of Health did not agree in court that the same level of care as received by patients at Life Esidimeni would be received at the NGOs. 5. Patients with intellectual disability have increased vulnerability because of associated stigma. The Life Esidimeni tragedy: A human-rights perspective 6. When individuals do not have decent levels of health, it is very difficult to exercise the fulfilment of human rights 7. International human rights instruments are not significant in the context of mental health. Informed consent and deafness in South Africa: Guidelines for clinicians and researchers 8. There is a significant history of exploitation and unethical experimentation with deaf people across the centuries. 9. The identity of being Deaf and the experience of being deaf and Deaf seems to transcend other identities, such as ethnicity. Do doctors attending sexual-offence victims have to notify sexualoffence suspects that their patients who were forced to have unprotected sexual intercourse are HIV-positive? What should doctors do? 10. The common law requires doctors to warn endangered third parties where such persons may suffer injury as a result of interactions with their patients. 11. The doctor-patient relationship is an example of a special relationship.

Transparency in medicines regulatory affairs – reclaiming missed opportunities 12. Transparency is not a value in the South African Constitution. 13. Constitutional rights are not absolute and can be infringed upon. How do healthcare professionals manage ethical challenges regarding information in healthcare professional/patient clinical interactions? A review of concept- or argument-based articles and case analyses 14. It is always clear how information should be managed within the clinical context. Public health officials and MECs for health should be held criminally liable for causing the death of cancer patients through their intentional or negligent conduct that results in oncology equipment not working in hospitals 15. Breaching the Public Finance Management Act will not result in criminal liability. 16. Murder is the unlawful and unintentional killing of another human being. A study of the role and functions of inspectors of anatomy in South Africa 17. Inspectors of anatomy do not monitor the use of human tissue for research purposes. 18. Regulations relating to human tissue banks have not as yet been promulgated in South Africa. The 2016 CIOMS guidelines and public-health research ethics 19. Public-health research prioritises health promotion and disease prevention among populations over protection of individuals. 20. Public health research ethics is relatively underdeveloped compared to other health-research ethics.

A maximum of 6 CEUs will be awarded per correctly completed test.

The CPD programme for SAJBL is administered by Medical Practice Consulting. CPD questionnaires must be completed online at www.mpconsulting.co.za After submission you can check the answers and print your certificate. Questions may be answered up to 6 months after publication of each issue. Accreditation number: MDB015/171/02/2017 (Ethics)

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